www.isoray.com Pioneering Internal Radiation Therapy with
Cesium 131 1 v092911
Slide 2
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 industrys 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. 2
Slide 3
Corporate Highlights Emerging market leader for internal
radiation therapy of cancer Based on exclusive patents for a
proprietary separation process for the Cesium 131 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 Cesium 131 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 Current: Prostate, Lung, Brain, Head/Neck, Ocular, Colon
and Gyn Pipeline: Breast, Esophageal, Pancreatic Additional market
expansion in combination with various existing delivery methods and
devices New GliaSite product line for treatment of brain cancer
3
Slide 4
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:
Cesium 131 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 A Better Solution 4
Slide 5
Cesium 131 Highlights Cesium 131 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 Pd 103 and I 125 IsoRay manufactures Proxcelan Cs 131
implantable seeds, used alone or in combination with devices such
as mesh, strands and sutures Proxcelan Cs 131 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 5
Slide 6
LDR Brachytherapy for Prostate Cancer Source: Mayo Foundation
Proxcelan Cs 131 Brachytherapy seeds Source: Oak Ridge Associated
Universities SAV I Catheter for Breast Cancer Source: Cianna
Medical 6
Slide 7
Cesium 131 Track Record Over 7,000 prostate cancer cases
treated with Proxcelan Cs 131 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 7
Slide 8
Benefits of Prostate Seed-Implants Source: Frost Sullivan
Report 2004 8
Slide 9
Advantages of Cesium 131 High Energy and Short Half Life Make
Cesium 131 the Isotope of Choice for Treatment of Many Disease
States Higher Initial Energy and Faster Delivery Time than Pd 103
and I 125 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) 9
Slide 10
ISOTOPEHALF-LIFE AVG THERAPEUTIC ENERGY TOTAL DOSE ANISOTROPY
FACTOR 90% DOSE DELIVERED Cs 131 9.7 days30.4 keV115 Gy.96933 days
Pd 103 17.5 days20.8 keV125 Gy.877 (TheraSeed 200) 58 days I 125 60
days28.5 keV145 Gy.930 (OncoSeed 6711) 204 days Brachytherapy
Implant Comparative Analysis 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. 10
Slide 11
GlioSite : Treatment of Brain Cancer GliaSite is IsoRays 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 I 125 is
already established for both in-patient and out-patient settings
Negotiating European distribution agreements Seeking FDA clearance
for new liquid form of Cesium 131 as alternative to the
radioisotope Iotrex (I 125 ) with GliaSite Cesium 131 benefits
expected to enhance market adoption rate, size and profit margin
GliaSite Balloon Catheter with Therapeutic Isotope 11
Slide 12
There were an estimated 1,479,350 1 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 11 th Edition (2008),
American Cancer Society 2010 Cancer Facts 12
Slide 13
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) *assuming the current reimbursement rates
(which are subject to annual review and adjustment), remain
constant Total IsoRay Market Potential:$150 Million* 13
Slide 14
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 Cesium 131 for
treatment of colon, head and neck cancer Develop breast and
esophageal cancer market Evaluate use of Cesium 131 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 14
Slide 15
Near Term Milestones Events to broaden prostate and other
cancer markets Independent publication of 5 year data for prostate
treatment Initiation of market use of Proxcelan Cs 131 for dual
therapy in high risk patients New MD Anderson clinical comparison
of Proxcelan Cs 131 with other isotopes Prelaunch marketing and
scientific presentations at Miami ASTRO conference Submission for
FDA approval of new liquid Cesium 131 formulation Multiple GliaSite
Events 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 Cs 131
with SAV-I void filling device for breast cancer Initiation of
esophageal cancer treatment with Proxcelan Cs 131 in combination
with an esophageal stent 15
Slide 16
Financials Year Ended June 30 US $20112010 Product
Sales5,238,9735,286,084 Gross Income1,157,417725,797
OpEx4,120,4054,734,697 Operating Loss(2,962,988)(4,008,900) Net
Loss(2,842,213)(4,033,856) Loss per Share(0.11)(0.18)
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 16
Slide 17
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 Enabled by
exclusive patent position for Cs-131 separation process Broadening
to other major cancer markets Multiple product and market
indications for cancer 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
Cesium 131 to all cancers Strong pipeline of near-term milestone
events 17
