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iCAD Corporate PresentationNASDAQ: ICAD
March 2020
Safe Harbor Statement
Certain statements contained in this presentation constitute “forward-looking statements” within the meaning ofthe Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve a number of knownand unknown risks, uncertainties and other factors which may cause the actual results, performance orachievements of the Company to be materially different from any future results, performance or achievementsexpressed or implied by such forward-looking statements. Such factors include, but are not limited to theCompany’s ability to defend itself in litigation matters, to achieve business and strategic objectives, the risks ofuncertainty of patent protection, the impact of supply and manufacturing constraints or difficulties, uncertaintyof future sales levels, protection of patents and other proprietary rights, product market acceptance, possibletechnological obsolescence of products, increased competition, litigation and/or government regulation, changesin Medicare or other reimbursement policies, risks relating to our existing and future debt obligations,competitive factors, the effects of a decline in the economy or markets served by the Company; and other risksdetailed in the Company’s filings with the Securities and Exchange Commission. The words “believe”,“demonstrate”, “intend”, “expect”, “would”, “could”, “consider”, “project”, “estimate”, “will”, “continue”,“anticipate”, “likely”, “seek”, and similar expressions identify forward-looking statements. Readers are cautionednot to place undue reliance on those forward-looking statements, which speak only as of the date the statementwas made. The Company is under no obligation to provide any updates to any information contained in thisrelease. For additional disclosure regarding these and other risks faced by iCAD, please see the disclosurecontained in our Annual Report or Form 10-K for the fiscal year ended December 31, 2018 filed with theSecurities and Exchange Commission on March 29, 2019.
2
Breakthrough Radiation Therapy – eBxRevolutionary Clinical AI Technology
iCAD: Two Core Technologies, Multiple Clinical Applications
Discovery • 1st to market with innovative software for 3D
mammography
• Breakthrough FDA claims in clinical performance & workflow
• Large installed base – 4,000+ customers globally
• Strong Partnerships
• Imaging OEMs
• PACS
• Platform expandable to other clinical applications
3
Recovery• Unique electronic brachytherapy platform
• FDA cleared, CE marked, & licensed OUS number; treatment anywhere in the body
• Core applications include:
• --Breast cancer
--Gynecological cancers
--Rectal and Neuro Cancers
--Prostate cancer (breakout potential)
• Aligned with emerging bundled & value-based healthcare initiatives
4
▪ Risk Factors
▪ Relatives with breast cancer
▪ Breast density
▪ Benign breast biopsy
▪ Race/ethnicity
▪ Menopausal status
▪ Menopausal hormone therapy
▪ Oral contraceptives
▪ Body mass index
▪ Months since last examination
Analog Mammography
Digital 2D Mammography
3D Tomosynthesis
Future-
Predictive Analytics
4th Generation AI Correlated Data - Cloud Based
Future-
Cloud Based AI
Partnership with Karolinska Institute- 70K Patient
Software as a Medical Device- FDA Label
2020 Release with 300% more images
Built on world’s largest dataset of AI Breast Images
Creating World’s 1st Radiomic, Genomic & Risk Factor Al Capability
Focused on accelerating adoption and building a4th Generation AI capability for the future
From 4 images to 300 images
5
Detection BusinessUnits, Total Available Market and Served Market
3D Tomosynthesis Market (units)
Initial Focus36,000 WW TAM
18,000
US TAM
9500
Installed 3D Units
$30,000
ASP
$3000
Service
$ Market Size
$1.2B WW TAM
$600M
US TAM
$315M
Served Market
Served Market growing at 500 new 3D units/quarter6
Clinical & Business Challenges Solved by ProFound AI
• Reading over 30,000 mammograms annually
• Volume of DBT cases/number of images per case
• Courtesy of Dr. Randy Hicks, MD. MBA, CEO RMI Michigan (10 sites)
7
Study # of Screening
Studies
Images/4 View Study
Total Images/Day
In One Week In 200 Day Year
2D 100 4 400 2,000 80,000
DBT 100 280 28,000 140,000 5,600,000
2.9 Days of 3D DBT reading equivalent to a years worth of 2D readingProFound AI reduced unnecessary call backs 30%
Find the soccer ball among the panda bears -- 1mm slices without PFAI
8
Find the soccer ball among the panda bears -- 1mm slices with PFAI
9
Individual Reader Performance without ProFound AI
10
• Wide variability in reader performance reading without AI– Sensitivity/Specificity: location of circle for
each reader
– Reading Time: size of circle
• AI operating point on enriched reader study dataset– High Case-level Sensitivity
– High Specificity (hard to achieve both)
• AI sensitivity higher than 22 of 24 readers without AI
• AI specificity lower than 20 of 24 readers without AI
ProFound AI standalone performance
Individual Reader Performance with ProFound AI
11
ProFound AI standalone performance
• Less variability in reader performance reading with AI
➢ Move together
• Improved sensitivity with AI for readers with high specificity without AI
➢ Move up
• Improved specificity with AI for readers with high sensitivity without AI
➢ Move to left
• Improved reading time with AI for readers with high sensitivity and high specificity without AI
15% misread cases before ProFound AI8% were missed without ProFound AI and 7% were unnecessarily called back
FDA results: 8% increased sensitivity, 7% fewer call backs. 52.8% reduced reading time, 58% for complex breast cases.
ProFound AI Doubles Detection Capability over 2D
2D
3D 3D w/ ProFound AI
AUC: 5.9% • Superior Specificity• Non-Inferior Sensitivity
• Superior Sensitivity• Superior Specificity• Superior Reading Time
AUC: 5.7% GE Reader Study Claims iCAD Reader Study Claims
5.9% in AUC
2D
11.6% with 3D plus ProFound AI Doubles Detection Performance at fraction of the price
5.7% in AUC
$300,000 ASP $30,000 ASP
12
Major Cost Avoidance
13
This alone leads to breakeven on a $30K license in just weeks and major cost avoidance over years… plus improved detection performance.
ProFound AI Channel Success
14
OEMs / Key Customer
GE Hologic
Siemens Fuji
Several enterprise-level customers with mixed OEM environments
ProFound AI Channel Success Cont’d
15
PACs & Mammo Workstations National Accounts
Focused on accelerating adoption and building a4th Generation AI capability for the future
▪ Risk Factors
▪ Relatives with breast cancer
▪ Breast density
▪ Benign breast biopsy
▪ Race/ethnicity
▪ Menopausal status
▪ Menopausal hormone therapy
▪ Oral contraceptives
▪ Body mass index
▪ Months since last examination
16
Analog Mammography
Digital 2D Mammography
3D Tomosynthesis
Future-
Predictive Analytics
4th Generation AI Correlated Data - Cloud Based
Future-
Cloud Based AI
Partnership with Karolinska Institute- 70K Patient
Software as a Medical Device- FDA Label
2020 Release with 300% more images
Built on world’s largest dataset of AI Breast Images
Creating World’s 1st Radiomic, Genomic & Risk Factor Al Capability
Risk Factors
60%
Risk Factors + AI Panorama
77%
Goal80% +
Our Vision is Panoramic
Solution examine the full picture including prior images* (3D & 2D) current image detection & short-term prospective individual risk*
Mapping a unique & personalized patient journey
(*Not yet commercially available.)
Current(Present)
Prospect*
(Future)Priors*
(Past)
18
Evolution of iCAD’s AI Technology from Detection to Prediction… with Panorama
50%Certainty
Score
Compared to =
69%AdjustedCertainty
Score
Short-Term Image-Based Risk Factors
50%Certainty
2020
30%Certainty
2019
17%Certainty
2018
69%AdjustedCertainty
Score=
Panorama will transform age-based screening to deliver risk-adjusted personalized detection
Compared to
Today
Future Personalized Risk Prospect Score
Compared to
+
=
You Today Your History Your Future =+ Panorama
Single Mammo Image Millions of Images
91%
27%
Personalized Risk Prospect Score
Now
So ProFound Panorama will not only will tell you where you are now….
19
Now
Where From Where To
Priors & Prospect will tell you where you’ve come from and where you’re heading
Our Vision is Panoramic
Innovative Radiation Therapy Platform
• Targeted, X-ray technology expands highly-focused treatment options for a range of cancers in a variety of medical settings
• Significant cost, mobility and treatment time advantages
• FDA cleared, CE marked and licensed in a growing number of countries for treatment anywhere in the body
• Core applications include breast, non-melanoma skin cancer, and GYN cancers
• Growing body of IORT clinical evidence with ~5 year follow up data with similar recurrence to 6 weeks of radiation therapy
• Excellent outcomes and superior cosmetic results compared to alternative treatments
• Substantial growth opportunities with expanded market share, additional applications and international expansion
21
Xoft Electronic Brachytherapy (eBx) System
Proprietary, miniaturized X-ray source
Highly-mobile controller
Balloon applicators (breast)
Surface applicators (skin)
GYN applicators
Xoft Core Technology & Platform
22
Products
System of Care
Core Technology
Plan – Treat – Verify
• World’s smallest therapeutic x-ray source
• Similar business core technologies that led to extensive value creation:• Cryo Ablation• RF Ablation• Laser Frequency Ablation
Xoft has a clear growth trajectoryAccelerating new product offerings based on market-driven feedback
23
Prostate
GYN
Breast
Neuro/Brain
Growth bolstered by new clinical data and emerging applications
Center of InfluencePhysicians
Rectal
2424
Evolving the Business Model
Brain Cancer
Breast Cancer
GI Cancer
GYN
Cancer
Prostate Cancer
Radiation Oncologist
Center of Influence Physician
Cancer Patients
Clinical Study
Hospital Admin
Advising Rad Onc
Physicist
Commercialization approach has shifted from a push-based model dependent upon the Rad Onc, to a pull-based model centered around a Center of Influence
Center of Influence is the epicenter of gatekeeper physicians, patient activation, and clinical innovation.CPT codes are now an accelerant – our business does not depend on them.
PUSH PULL
Recurrent GBM – Presented at EANS 2019 by European Medical Center, Moscow
30 patients treated at 2 institutions between August 2016 and September 2019
Matched Pair Study: Group A: (15 Patients) Xoft IORT 20 Gy - Group B: (15 Patients) External Beam Radiotherapy
Median Overall Survival24 months
(range 13.5-48.5 months)
Median Overall Survival21 months
(range 5.5 – 38.5 months)
7 8
159 of 15 patients in Group A were still
alive with no local recurrence0 of 15 patients were still alive
in Group B
0123456789
101112131415
0 5 10 15 20 25 30 35 40
Nu
mb
er o
f P
atie
nts
Months Following Surgery
Survival and Disease-Free Survival
Disease-Free Survival - Xoft
0123456789
101112131415
0 5 10 15 20 25 30 35 40
Nu
mb
er o
f P
atie
nts
Months Following Surgery
Survival and Disease-Free Survival
Disease-Free Survival - Control
12 Months16 Months
9.5 Months
3.5 Months
26
Xoft Reimbursement Update
Rad Onc APM/RO OPPS APM/Hospital
Breast IORT $503 $2,074 $7,942 $9,740
Prostate IORT $503 $3,228 $7,942 $19,852
Rectal IORT $503 $2,369 $7,942 $11,589
APM Provider Financial Impact
• New bundled model incentivizes provider selection of cost-effective treatment
• Xoft single patient encounter vs. multiple fraction delivery attractive to providers
CMS has not made a final ruling of the July 2019 proposed new codes
27
Investment Thesis
• Strong leadership positions across a range of revolutionary medical technologies • Cancer Detection• Cancer Therapy
• Uniquely positioned to capitalize on explosive growth in AI
• Established installed base
• Operating in substantial, growing addressable markets
• Significant opportunity to expand IORT applications globally
• Promising R&D pipeline with strong potential for expansion of 2 core technologies
• Promising reimbursement landscape aligned with value based care and drive to quality of quantity of care
• Motivated employees driven to deliver future wins
28
A global medical technology leader providing innovative cancer detection and therapy solutions.
Appendix
The Power of AI in Mammography Reading
4-mm spiculated mass detected by ProFound AI
Without ProFound AI: 6 of 24 radiologists detected cancer
With ProFound AI: 18 of 24 radiologists detected cancer (3-fold increase)
ProFound AI found it 100% of the time.
ProFound AI is CE Mark Approved & Health Canada Licensed. U.S. FDA Cleared December 2018. 30
Financial Highlights – YTD Q4 2019 vs 2018 Revenue
31
• Two scalable business segments• Total revenue -> 22% increase• Detection segment revenues are growing
• Detection revenue -> 32% increase
• Stable revenue mix• Service revenue ->37% of total revenue• Product revenue -> 51% increase
13,111
19,766
12,510 11,574
0
5,000
10,000
15,000
20,000
25,000
Q4-18 Q4-19
(00
0's
)
Revenue by Type
Product
Service
16,864
22,319
8,757 9,021
-
5,000
10,000
15,000
20,000
25,000
Q4-18 Q4-19
(00
0's
)
Revenue by Segment
Detection
Therapy
Financial Highlights – Quarter ended Q4 2019
32
Attractive gross margins
• Q4 ‘19 YTD Gross Margin → 77%• Detection (AI Business) Margin → 83%• Therapy Margin → 62%
Sufficient capital • Cash and cash equivalents as of 12/31/19 = $15.3M
Debt
• Term Loan: $4.2M (Prime Rate)
• Convertible Debt: $7.0M Principal value (5% coupon, $4.00 conversion price, matures 12/21/2021) , Conversion forced during February 2020
Shares Outstanding • 19.5M Common Shares
33