confidently live life with ease
Management Presentation
1
Forward-Looking Statements
This presentation contains certain forward-looking statements
that involve risks and uncertainties that could cause actual
results to be materially different from historical results or from
any future results expressed or implied by such forwardlooking statements.
In some cases, you can identify forward-looking statements by the words “expect,” “intend,” “target,”
“plan,” “estimate,” “predict,” “opportunity,” and “continue,” or the negative of these terms, or other
comparable terminology intended to identify statements about the future. Forward-looking
statements include statements about future demand for our Eversense™ System and future
products, if any, that we may develop; the growth of the CGM market; the factors that we believe
drive demand for our Eversense™ System and our ability to sustain such demand; the size of the
market and competitive landscape for our Eversense™ System; the initiation, timing, progress and
results of our clinical trials; our plans for the Eversense™ System and our expectations about
completion of its development and the timing of the submission for regulatory approval by the FDA,
and the timing for receiving such approvals; our enhancement of the Eversense™ System,
including the extension of sensor life and improvements in accuracy; launch of the Eversense™
System in the United States and European countries; expected long-term gross profit margins; our
plans for pursuing coverage and reimbursement for our Eversense™ System; our ability to protect
and enforce our intellectual property rights; and anticipated trends and challenges in our business
and the market in which we operate.
These statements involve known and unknown risks, uncertainties and other factors that may
cause our actual results, levels of activity, performance or achievements to be materially different
from the information expressed or implied by these forward- looking statements. Although we
believe that we have a reasonable basis for each forward-looking statement contained in this
presentation, we caution you that these statements are based on a combination of facts and factors
currently known by us and our expectations of the future, about which we cannot be certain.
Factors that may cause actual results to differ materially from any future results expressed or
implied by any forward-looking statements include the risk that we may not achieve greater market
acceptance of our Eversense™ System; the risk that we may not be able to establish sales and
marketing capabilities in order to meet demand for our Eversense™ System; risks associated with
competition in the diagnostics industry; risks associated with the performance of our Eversense™
System; the risk that we may not receive regulatory clearance for our Eversense™ System in the
United States; the risk that we may not be able to comply with extensive ongoing regulatory
requirements; risks associated with reliance on a limited number of suppliers; the risk that we may
not be able to successfully develop or introduce new or other applications of our technology at all or
in a timely manner; the risk that we may not be able to maintain and expand coverage and
reimbursement from health insurers and other third-party payers; risks associated with limited
patent protection; the risk that we may not successfully manage our growth; and risks associated
with reliance on outside financing to meet capital requirements. For further information regarding
these risks, uncertainties and other factors you should read the “Risk Factors” section of our
Annual Report on Form 10-K for the year ended December 31, 2015, our Quarterly Report on
Form 10-Q for the quarter ended June 30, 2016 and our other filings we make with the Securities
and Exchange Commission from time to time.
Any forward-looking statements speak only as of the date of this presentation. We undertake no
obligation to publicly update any forward-looking statements, whether as a result of new
information, future events or otherwise.
This presentation also contains estimates and other statistical data made by independent parties
and by us relating to market size and other data about our industry. This data involves a number of
assumptions and limitations, and you are cautioned not to give undue weight to such estimates. In
addition, projections, assumptions and estimates of our future performance and the future
performance of the markets in which we operate are necessarily subject to a high degree of
uncertainty and risk.
confidently live life with ease
. . .
Develop and commercialize
transformative glucose
monitoring products.
3
Eversense CGM System is CE marked and approved for sale in Europe. Eversense CGM System is an Investigational Device and is limited by Federal Law to investigational use in the United States.
CGM Gives You Better Insight
Eversense
Glucose Readings
350
300
250
SMBG
SMBG
Glucose
Concentration
200
(mg/dL)
150
HYPERGLYCEMI A
SMBG
SMBG
100
50
Target Range
HYPOGLYCEMI A
0
8AM
14.00
12PM
22.00
0.00
4PM
8PM
4.00
2.00
6.0012PM
8.00
4AM 10.00
Time
4
Eversense CGM System is CE marked and approved for sale in Europe. Eversense CGM System is an Investigational Device and is limited by Federal Law to investigational use in the United States.
The Market Is Quickly Growing
$8
10
$7
6
Europe
Europe
4
$5.8
$5
$4
U.S.
2015
2020
$0
Intensively Managed Population
$2.5
$2
$1
U.S.
$3.5
$3.3
$3
2
0
$6.5
$6
Revenue In Billions
Millions of Patients
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CGM
fastest
growing
segment
$0.7
2015
2020
Est.
2015
2020
Est.
2015
2020
Est.
CGM*
Insulin Pumps
SMBG
~35 – 40% CAGR
~8% CAGR
~(2%) CAGR
Type 1 CGM penetration, in the US,
projected to grow from 8% to 45% by 2020
5
Eversense CGM System is CE marked and approved for sale in Europe. Eversense CGM System is an Investigational Device and is limited by Federal Law to investigational use in the United States.
Opportunities to Improve Patient Acceptance
top 5 reasons why people discontinue CGM...
Real-Time
Continuous Glucose
Monitoring Among
Participants in the
TID Exchange
Clinic Registry
Wong J.C et al, Diabetes Care
2014;37:2702–2709 | DOI:
10.2337/dc14-0303
1
2
3
Discomfort
when wearing
CGM
Problems
inserting
sensor
4
5
Problems
with
adhesive
holding
sensor on
the skin
Accuracy
Sensor skin
reactions
6
Eversense CGM System is CE marked and approved for sale in Europe. Eversense CGM System is an Investigational Device and is limited by Federal Law to investigational use in the United States.
The Eversense System
Sensor
Smart Transmitter
Mobile App
Sensor that lasts up to 180 days
Removable and rechargeable
No extra device to carry
No weekly sensor insertion
On-body vibe alerts
iOS and Android platform
No open wound
Gentle-on-skin adhesive
Alarm settings & reports
7
Eversense CGM System is CE marked and approved for sale in Europe. Eversense CGM System is an Investigational Device and is limited by Federal Law to investigational use in the United States.
Established, Proven
Sensor Technology
Non-enzymatic, fluorescence
based measurement
Biocompatible
Encasement
Optical
Interface
Polymer
Hydrogel
Simple in-office procedure
– less than 5 mins
Best-in-class accuracy
Lasts up to 180-days
without removing
Tested in over 900 sensors in 500
patients, 100,000 sensor wear days
NFC
Antenna
no
weekly
sensor
insertion
no open
wound
no sensor
wasted
when
transmitter
removed
Eversense CGM System is CE marked and approved for sale in Europe. Eversense CGM System is an Investigational Device and is limited by Federal Law to investigational use in the United States.
8
on body alerts
for extra security
9
Eversense CGM System is CE marked and approved for sale in Europe. Eversense CGM System is an Investigational Device and is limited by Federal Law to investigational use in the United States.
Eversense Mobile Platform Enables Advanced Features
Predictive Low/High
Glucose Alerts &
Rate of Change Alerts
Remote Monitoring
with Eversense Now
Reports Directly on App
Email PDF
report to
caregiver
Readings on
Applewatch
10
Eversense CGM System is CE marked and approved for sale in Europe. Eversense CGM System is an Investigational Device and is limited by Federal Law to investigational use in the United States.
Industry leading accuracy
U.S. PRECISE II
Study Completed
MARD
8.8%
Glucose range
of 40-400 mg/dL
largest continuous single-sensor
pivotal study in the world
Throughout
90-day use
16,000+ paired data points,
2,000,000+ sensor glucose readings
•
Determine safety and
accuracy
•
Prospective, single-arm
multi-center investigation
•
90 adults with diabetes
•
1 sensor inserted for
90 days in upper arm
•
Utilized improved
glucose algorithm
•
Data for PMA submission
11
Eversense CGM System is CE marked and approved for sale in Europe. Eversense CGM System is an Investigational Device and is limited by Federal Law to investigational use in the United States.
Patient Feedback
95%
92%
84%
88%
Ease
of Use
No Pain /
Discomfort
Want to be
Inserted Again
Would Like to
Use Every Day
“Significant
“The
“My
device
“When
patient
reduction
shows
you
wasboth
work
inofnear
glycemic
hypoglycemia
a lot
tears
andvalue
when
are on
due
and
thethe
to
study
itsmove
early
trend
ended
constantly,
warning
andand
leads
she
→ittosafety
had
ishypoglycemia
gold
togain
give
worth
→
back
not
life
disappearance…
the
having
quality
device.”
↑↑↑ !!!!
to take blood samples. It
isI extra
have
very
exercised
security
easy to
tomuch
have
use.”
more.”
theCenter
alarm directly on the body.”
– Jort
Kropff,
MD Amsterdam
Medical
––Romanian
German
– Sweden
study
study
user
participant
participant
(July 2016)
(2015)
(2014)
12
Eversense CGM System is CE marked and approved for sale in Europe. Eversense CGM System is an Investigational Device and is limited by Federal Law to investigational use in the United States.
Physician Feedback
“One of the features of
endocrinology that appealed
to me is the relative absence
of procedures. After
performing the sensor
insertion, I realized that
I no longer fear procedures.
I felt very comfortable
after the first two sensors.”
“It was surprising
how easy the insertion
procedure was.”
Dr. Manuela Link,
Institute for Diabetes Technology,
Ulm, Germany
Dr. Mark Christensen,
Diablo Clinical Research,
Walnut Creek, California
“I don’t understand
why some would think
implanting a sensor
would be difficult without
having any first hand
knowledge of the procedure.
We’re transitioning
into ‘interventional
endocrinologists’ to meet
the needs of our patients.”
Dr. Timothy Bailey,
AMCR Institute,
Escondido, California
13
Eversense CGM System is CE marked and approved for sale in Europe. Eversense CGM System is an Investigational Device and is limited by Federal Law to investigational use in the United States.
Strategic Positioning For Maximum Acceptance
leverage
channels
Utilize
experienced
distributors OUS
Build strong
direct sales
force in US
competitive price
to healthcare system
Target key
clinic and
patient base
secure comprehensive
reimbursement
CPT category
III codes issued
Medical
benefit
Positive coverage
decision for CGM
Total price reflects
reimbursement
to endos
Reduced co-pays
with bi-annual
sensor purchase
Reduce number
of components
to purchase
innovative product
and program offering
Product introductions
to grow share
and market
Strong
product
pipeline
Awareness
and training
programs
14
Eversense CGM System is CE marked and approved for sale in Europe. Eversense CGM System is an Investigational Device and is limited by Federal Law to investigational use in the United States.
Selling in Sweden June 2016
Launch in Norway, Denmark 4Q16
Launch in Germany September 2016
Launch in Italy, Netherlands 4Q16
EU Distributor Status
15
Eversense CGM System is CE marked and approved for sale in Europe. Eversense CGM System is an Investigational Device and is limited by Federal Law to investigational use in the United States.
Europe Launch (2016)
US Launch (2017)
Europe Launch Target (2017 future markets)
Commercialization Strategy
focused on addressable CGM markets
16
Eversense CGM System is CE marked and approved for sale in Europe. Eversense CGM System is an Investigational Device and is limited by Federal Law to investigational use in the United States.
Sales Force Role By
Activity and Segment
Provide clinic training and
reimbursement claims support
Payers
N/A
KOLs
Sales
Rep
Clinical
Training
Mgr
Endos
Sales
Rep
Clinical
Training
Mgr
Diabetes
Eds
Focus on targeted high-insulin
prescribing clinics
Key Acct
Mgrs
Sales
Rep
N/A
Patients
Begin sales management
and managed care sales
account hiring mid-2017
Segments
US Sales Approach
build commercial infrastructure to drive revenue
Device Training
By Sales, Clinic
Sales
Call
Sensor
Training
Activities
17
Market Reimbursement
Strategy
create predictable reimbursement
environment for healthcare providers
Category III Codes
• 04X1T Creation of subcutaneous pocket
with insertion of implantable interstitial
glucose sensor, including system activation
and patient training
• 04X2T Removal of implantable interstitial
glucose sensor from subcutaneous pocket
via incision
• 04X3T Removal of implantable interstitial
glucose sensor with creation of subcutaneous
pocket at different anatomic site and
insertion
of new implantable sensor, including system
activation
1
Secured reimbursement codes
for insertion procedure
2
Fold into existing coverage,
policy or hospital tender decisions
3
Position product as similar to other
CGMs with value-added feature set
18
Eversense CGM System is CE marked and approved for sale in Europe. Eversense CGM System is an Investigational Device and is limited by Federal Law to investigational use in the United States.
Product
Strategy
Reduce
Calibration
Approve for
Pediatrics
Integrate with
Insulin Pump
Lower
Cost
Broaden
Target Market
Extend
Duration
Improve
Accuracy
19
Eversense CGM System is CE marked and approved for sale in Europe. Eversense CGM System is an Investigational Device and is limited by Federal Law to investigational use in the United States.
Product Pipeline
Products to grow market share
Products to broaden target market
Intensively Managed Patients
Insulin Using Patients and Type 2 Patients
Eversense 180
On-Demand
full 180 day with dosing claim
Flash Glucose Monitoring
Eversense for Pediatric Use
Gemini
Eversense with Pump Integration
2 in 1
MDI
Patients
Pump
Patients
Non-MDI
Patients
OAD
Patients
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Eversense CGM System is CE marked and approved for sale in Europe. Eversense CGM System is an Investigational Device and is limited by Federal Law to investigational use in the United States.
Reduce Calibration Sensor
user
convenience
1-Cal Sensor, MARD 9.5%
2-Cal Sensor, MARD 8.8%
400
400
350
350
Lab
Reference
250
200
Eversense
Glucose Readings
150
SMBG
250
200
SMBG
100
Target Range
50
50
0
0
22:00
Eversense
Glucose Readings
150
SMBG
100
Lab
Reference
300
Glucose (mg/dL)
Glucose (mg/dL)
300
same
sensor
02:00
06:00
10:00
14:00
18:00
22:00
Target Range
02:00
06:00
10:00
14:00
18:00
21
Eversense CGM System is CE marked and approved for sale in Europe. Eversense CGM System is an Investigational Device and is limited by Federal Law to investigational use in the United States.
On-Demand
Implanted 180 day sensor,
smartphone app,
no transmitter worn
Direct sensor
communication with NFCinterfaced smartphone
the long-term flash glucose
monitoring with no transmitter
NFC-interfaced phones act as
transmitter and receiver; powers
and reads implanted sensor
22
Eversense CGM System is CE marked and approved for sale in Europe. Eversense CGM System is an Investigational Device and is limited by Federal Law to investigational use in the United States.
Gemini
the ultimate flexibility
for your daily life
23
Eversense CGM System is CE marked and approved for sale in Europe. Eversense CGM System is an Investigational Device and is limited by Federal Law to investigational use in the United States.
Senseonics Milestones
Q1
2016
1H
2016
1H
2016
1H
2016
Initiated U.S.
Pivotal Trial
CE Mark
Approval
Commercial Launch
Sweden
CE Amendment
Application 180 Day
2H
2016
2H
2016
2H
2016
2H
2016
Complete U.S.
Pivotal Trial
Submit
PMA
Commercial Launch
Germany, Italy, Netherlands,
Norway, Denmark
Launch Gen 2
Transmitter
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Eversense CGM System is CE marked and approved for sale in Europe. Eversense CGM System is an Investigational Device and is limited by Federal Law to investigational use in the United States.
confidently live life with ease
Management Presentation
25