www.isoray.com
Pioneering Internal Radiation
Therapy with Cesium131
v092911
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Forward Looking Statements
This presentation contains forward-looking statements. These statements relate to
future events or our future financial performance and involve known and unknown
risks, uncertainties and other factors that may cause our or our industry’s actual
results, levels of activity, performance or achievements to be materially different
from any future results, levels of activity, performance or achievements
expressed, implied or inferred by these forward-looking statements. In some
cases, you can identify forward-looking statements by terminology such as “may,”
“will,” “should,” “could,” “would,” “expects,” “plans,” “intends,” “anticipates,”
“believes,” “estimates,” “predicts,” “projects,” “potential” or “continue” or the
negative of such terms and other comparable terminology.
These statements are only predictions based on our current expectations and
projections about future events. You should not place undue reliance on these
statements. Actual events or results may differ materially. In evaluating these
statements, you should specifically consider various factors, including the risks
outlined under “Risk Factors” in our Annual Report on Form 10-K filed with the
SEC on September 28, 2011. These and other factors may cause our actual
results to differ materially from any forward-looking statement. We undertake no
obligation to update any of the forward-looking statements after the date of this
presentation to conform those statements to reflect the occurrence of
unanticipated events, except as required by applicable law.
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Corporate Highlights

Emerging market leader for internal radiation therapy of cancer
 Based on exclusive patents for a proprietary separation process for the



Cesium131 isotope
Lead products launched and markets growing
FDA cleared for use in all body sites and tumor types
A superior solution for brachytherapy of cancer
 Cesium131 products offer safe and effective results compared with:
 external radiation and surgery
 internal radiation therapy with other isotopes

Multiple cancer indications in US and EU markets

Additional market expansion in combination with various existing
delivery methods and devices
 Current: Prostate, Lung, Brain, Head/Neck, Ocular, Colon and Gyn
 Pipeline: Breast, Esophageal, Pancreatic
 New GliaSite® product line for treatment of brain cancer
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A Better Solution
Dr. Dattatreyudu Nori, professor of clinical radiology at
Weill Medical College of Cornell University and radiation
oncologist-in-chief at New York-Presbyterian/Weill Cornell
says:
“Cesium131 brachytherapy is nothing less than a new
standard of care for treatment of prostate cancer, giving
patients an improved quality of life and peace of mind.”
Medical News Today – UK, January 8th, 2006
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Cesium131 Highlights

Cesium131 isotope offers superior results compared to competitive
isotopes due to:
 High energy; and
 Short (9.7 day) half life

Delivers effective dose 2 - 6 times faster than Pd103 and I125

IsoRay manufactures Proxcelan™ Cs131 implantable seeds, used
alone or in combination with devices such as mesh, strands and
sutures

Proxcelan™ Cs131 seed implant is placed in or around the tumor, or
on the surgical margins of a suture site

Minimally invasive
 Seeds are placed via needle, sutures, or mesh, and can be directly placed at time
of tumor removal
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Proxcelan™ Cs131
Brachytherapy “seeds”
LDR Brachytherapy for Prostate
Cancer
Source: Oak Ridge Associated Universities
SAV I Catheter for
Breast Cancer
Source: Mayo Foundation
Source: Cianna Medical
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Cesium131 Track Record



Over 7,000 prostate cancer cases treated with Proxcelan™ Cs131
New 5 year prostate cancer treatment data indicate strong efficacy

98% success (measured by freedom from biochemical failure)
Leading medical institutions are currently collecting data for
treatment for the following indications:






Prostate
Lung
Brain
Ocular
Colon
Head and Neck
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Benefits of Prostate Seed-Implants
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Source: Frost Sullivan Report 2004
Advantages of Cesium131
High Energy and Short Half Life Make Cesium131 the Isotope
of Choice for Treatment of Many Disease States
 Higher Initial Energy and Faster Delivery Time than Pd103 and I125



Dose is delivered in advance of absorption of delivery vehicles (mesh and
suture materials)
Cancer cells have less opportunity to repopulate
Greater flexibility due to reduced total radiation to healthy
tissues
 Uniform and Symmetrical Radiation Penetration


Improved dose distribution (homogeneity)
Improved placement positioning
 Single Application
Autoradiograph of an IsoRay seed (4.5 mm)
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Brachytherapy Implant Comparative Analysis
ISOTOPE
HALF-LIFE
Cs131
9.7 days
Pd103
I125
17.5 days
60 days
AVG
THERAPEUTIC TOTAL DOSE
ENERGY
30.4 keV
20.8 keV
28.5 keV
ANISOTROPY
FACTOR
90% DOSE
DELIVERED
115 Gy
.969
33 days
125 Gy
.877
(TheraSeed®
200)
58 days
145 Gy
.930
(OncoSeed®
6711)
204 days
The above information is considered standard dosing information. Such information is governed by the FDA and is required to
accompany any product that is distributed to a customer and intended for use. Acquisition of this information can be obtained from the
company that manufactures each listed product.
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GlioSite ® : Treatment of Brain Cancer
GliaSite® Balloon Catheter with
Therapeutic Isotope


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GliaSite® is IsoRay’s newest product offering
•
The only FDA-approved balloon catheter for brachytherapy of brain cancer
Product launch preparations underway in the US
•
Reimbursement of the GliaSite® system with I125 is already established for both
in-patient and out-patient settings
Negotiating European distribution agreements
Seeking FDA clearance for new liquid form of Cesium131 as
alternative to the radioisotope Iotrex™ (I125) with GliaSite®
•
Cesium131 benefits expected to enhance market adoption rate, size and profit
margin
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Cancer Facts
There were an estimated 1,479,3501 new cases of cancer
diagnosed in the U.S. in 2010:
Prostate – 217,730
Lung – 222,520
Head and Neck – 52,540
Brain – 22,020
Eye and Orbit – 2,480
Breast – 209,000
Colon – 102,900
1- Cancer Statistics, 2010 Jemal et al., Cancer Management: A Multidisciplinary Approach 11th Edition (2008), American Cancer
Society 2010
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IsoRay Market Potential

Head and Neck: 2,000 potential cases ($5,950,000.00)
(2000 cases x $119 x 25 seeds)

Lung: 4,000 potential cases ($19,040,000.00)
(4000 cases x $119 x 40 seeds)

Prostate: 13,000 potential cases ($79,560,000.00)
(13,000 cases x $72 asp x 85 seeds)

Ocular Melanoma: ~200 potential cases ( $350,000.00)
(200 cases x $119 x 15 seeds)

Brain Cancer (GBM): ~2,000 potential cases ($7,140,000.00)
(2000 cases x $119 x 30 seeds)

Breast: 10,000 potential cases ($47,600,000.00)
(10,000 cases x $199 x 40 seeds)
Total IsoRay Market Potential:$150 Million*
*assuming the current reimbursement rates (which are subject to annual review and adjustment), remain constant
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Corporate Strategy

Continue to grow prostate cancer market share

Leverage new positive 5 year data to increase adoption rates

Aggressively market the new GliaSite® system for revenue expansion
in the brain cancer treatment market

Capture the lung cancer market
•


Independent multi-center study now underway
Promote Cesium131 for treatment of colon, head and neck cancer
Develop breast and esophageal cancer market
 Evaluate use of Cesium131 in combination with the SAV-I void filling device and
others for treatment of breast cancer

Expansion of marketing and distribution in US and the EU
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Near Term Milestones

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Events to broaden prostate and other cancer markets
•
•
•
•
Submission for FDA approval of new liquid Cesium131 formulation
Multiple GliaSite® Events
•
•
•
•

Independent publication of 5 year data for prostate treatment
Initiation of market use of Proxcelan™Cs131 for “dual therapy” in high risk patients
New MD Anderson clinical comparison of Proxcelan™ Cs131 with other isotopes
Prelaunch marketing and scientific presentations at Miami ASTRO conference
Review by notified body for CE mark approval
Pending State of Washington approval of radioisotope product manufacturing and
delivery to enable initiation of GliaSite® launch
Completion of EU distributorship for GliaSite®
US and EU launch of GliaSite® !
Expansion to new cancer treatments
•
•
Market use of Proxcelan™ Cs131 with SAV-I void filling device for breast cancer
Initiation of esophageal cancer treatment with Proxcelan™ Cs131 in combination
with an esophageal stent
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Financials
Year Ended June 30
US $
2011
2010
5,238,973
5,286,084
1,157,417
725,797
4,120,405
4,734,697
Operating Loss
(2,962,988)
(4,008,900)
Net Loss
(2,842,213)
(4,033,856)
(0.11)
(0.18)
Product Sales
Gross Income
OpEx
Loss per Share
Cash/Equivalents
$2,112,254

Operating loss reductions from decreasing cost of product and sales,
and large reduction in cash burn

Continuing trend for increased margins as well as new revenue growth
projected with new uses and products in non-prostate cancer
applications
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Summary

Non-prostate applications grew 139% from FY2010 to FY2011

Positioned to be the leader for brachytherapy cancer treatment
with a $150+ million potential market share



Broadening to other major cancer markets
Multiple product and market indications for cancer



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Enabled by exclusive patent position for Cs-131 separation process
Current leading prostate cancer treatment, with active expansion to lung
and brain cancer treatments
GliaSite® system to enable new brain cancer treatment
FDA approved to take Cesium131 to all cancers
Strong pipeline of near-term milestone events
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ISORAY
WHERE THE FUTURE IS NOW
Thank You!
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