The Company
Positron Corporation is a leading molecular imaging
healthcare company providing innovative technologies and
solutions that are reshaping the field of nuclear
cardiology. Through our proprietary PET imaging systems,
services and radiopharmaceutical solutions, Positron enables
healthcare providers to more accurately diagnose disease and
improve patient outcomes while practicing cost effective
medicine.
Positron, a true pioneer in cardiac Positron Emission
Tomography (PET), is well branded in the field of nuclear
cardiology. Originally a research and development
company focused on technology, Positron's business
strategy has evolved over the past 3 years from an imaging
device manufacturer to a company that provides a
comprehensive "full nuclear cardiology solution."
Positron's business strategy is to obtain a dominant
market share through the vertical integration of such key
components as: imaging technologies, clinical services,
radiopharmaceutical manufacturing, processing & distribution
and radioisotope production & supply. Positron intends
to maximize market share by offering cost-effective, value
added solutions to end-users, with the objective of becoming
a sustained long-term value creator for industry participants
and shareholders.
KEY COMPONENTS
Positron's strategy of vertically integrating all key
components is enabled through the following products, segments
and services:
PET Imaging System and Services
The Attrius®, dedicated PET imaging system, is optimized
for cardiology. Positron's Attrius provides customers with
state-of-the-art imaging technology for the diagnosis,
treatment and prevention of cardiovascular disease. The Attrius
is the only dedicated PET scanner in the world and was awarded
Frost & Sullivan's Most Innovative Medical Device of the
Year in 2010, as "the ideal solution for cardiologists and
hospitals looking to add high accuracy, cost effective imaging
technology." Positron complements its technology by
offering comprehensive world-class clinical, technical and
service support through their PosiStar™ customer care
plan.
Radiopharmaceutical
Manufacturing/Processing/Distribution
Positron manufactures and processes radiochemicals at its
cGMP and NRC licensed manufacturing facility. Upon FDA
approval, Positron will enter radiopharmaceutical markets with
high demand products as a precursor for its PET
radiopharmaceuticals initiatives. Positron plans to license
and/or introduce its own proprietary cardiac PET generator and
infusion system. The Company will also distribute select
radiopharmaceuticals through its PosiRx™ automated
radiopharmaceutical system for on-site preparation and
dispensing of radiopharmaceuticals.
Radioisotopes Production
With Positron's recent acquisition of Manhattan
Isotope Technology LLC, Positron is the only commercial
resource in the US with practical knowledge and experience in
all stages of strontium-82 production and spent generator
lifecycle management. Positron seeks to secure both the short &
long term supply of radioisotopes used in cardiac PET imaging.
The Company intends to increase the Sr82 supply through the
production of Sr-82 from domestic & foreign suppliers and
recycling of Sr-82 from spent generators. In our pursuit
of securing a North American supply of radioisotopes used in
cardiac PET imaging, Positron plans to build and operate the
world's largest commercial high energy/high current
cyclotron (70MeV) within the U.S. The 70
MeV cyclotron will be at the heart of providing a
reliable, dependable, indigenous supply of radioisotopes in the
US thereby stabilizing and building confidence in the PET
market and nuclear medicine community overall. Securing a
reliable supply of radioisotopes will increase the demand for
Positron's pharmaceuticals, imaging equipment and
services.
Financing Solutions
Positron will provide customers with a variety of
financing solutions for its full solutions model designed to
minimize any barriers to entry, thus accelerating the expansion
of cardiac PET and further securing Positron's current and
future position in the market.
Positron is redefining the nuclear imaging market by
actively pursuing key initiatives that will ensure the growth
of the industry and the longevity of the Company. One of
these key initiatives involves lowering barriers that have
been, or could later constrict the progress of technological
advancements in nuclear cardiology. These barriers include:
high cost of equipment, limited supplies of key
radioisotopes, limited availability of radioactive waste
management facilities, and overcoming an existing monopoly of
centralized radiopharmacies in radiopharmaceutical
distribution. Positron's vertically integrated solution
allows the Company to aggressively address each of these
factors in an effort to become the premier, full service
provider in the nuclear imaging market.
Positron Corporation is a publicly listed company and
files annual, quarterly, special reports, proxy statements
and other information with the SEC. Shares of common stock of
Positron Corporation are currently trading on the National
Association of Securities Dealers, Inc.'s OTC Bulletin
Board under the symbol POSC.OB.
Target Markets
Nuclear medicine helps in the diagnosis, management and
prevention of patients with cardiovascular disease (CVD).
Radiopharmaceuticals are injected into a patient to provide the
most accurate, non-invasive test for identifying narrowed
coronary arteries, mild cholesterol build-up or diffuse
coronary vascular disease; conditions that are responsible for
almost all heart attacks. Cardiovascular disease is the leading
cause of death in the United States and constitutes 17% of
overall national health expenditures (Forecasting the Future of
Cardiovascular Disease in the United States, American Heart
Association, 2011). Direct CVD costs are projected to
increase from $273 billion in 2010 to $818 billion in 2030, and
indirect costs (due to lost productivity) will rise from $172
billion in 2010 to $276 billion in 2030.
There are two major modalities in nuclear cardiology
imaging that help in detecting and diagnosing CVD;
Single-Photon Emission Computed Tomography (SPECT) and
Positron Emission Tomography (PET), these modalities
represent two different segments of the cardiac imaging
market.
SPECT
SPECT is a comparatively dated technology in a market
that is mature, if not oversaturated. More than 85% of SPECT
cameras are purchased as replacements for existing practices
(Nuclear Medicine Market Outlook Report, IMV 2011).
Additionally, 31%, or approximately 4,100 SPECT cameras in the
U.S. are dedicated to cardiac imaging.
According to BIO-TECH, in 2010, total sales of SPECT
radiopharmaceuticals were $758 million. Among these, sales of
the major cardiac SPECT radiopharmaceuticals, Cardiolite,
Myoview and Sestamibi, were around $575 million. It is
expected that this market will grow to $620 million in 2012
and be effectively flat thereafter.
Positron intends to enter this large market with
PosiRx, a system that automates the elution, preparation, and
dispensing processes for radiopharmaceutical agents used in
SPECT cardiac imaging. The Company believes that PosiRx will
revolutionize the industry by offering a unique alternative
to the current paradigm of handling and distribution of SPECT
radiopharmaceuticals through centralized radiopharmacies
throughout the country. The optimal target customers for
PosiRx are cardiac clinics and hospitals with an average to
high volume of SPECT myocardial ischemia perfusion studies.
Depending on the success of our PosiRx revenue models,
Positron anticipates approximately $1 million in revenue in
2012 and greater than $18 million annually by 2015.Projected
revenue may increase from successful relationships with group
purchasing organizations and the Company's expansion into
high growth emerging markets outside the United States. The
Company believes these opportunities may hold significant
growth potential due to the shift in regulations, strive to
improve economics and lack of infrastructure outside the
United States.
PET
PET is a more advanced and accurate technology. In
cardiac perfusion imaging, PET scanners, in particular
Positron's Attrius, have superior sensitivity and
specificity compared to that of SPECT cameras. PET also
produces less radiation exposure and is capable of performing
quantitative measurements. Cardiac PET imaging has been shown
to provide a 50% reduction in invasive coronary arteriography
and coronary artery bypass grafting, leading to a 30% costs
savings and excellent clinical outcomes compared to SPECT (M.E.
Merhige, M.D., et al. Journal Nuclear Medicine 2007; 48:
1069-1076).
The cardiac PET equipment market is much smaller than
SPECT but has seen significant annual growth, of 25-30%,
during the last decade. According to Bracco Diagnostics,
there were approximately 160 dedicated cardiac PET & PET/CT
scanners within the U.S. in 2010. Millennium Research
Group projects 20% average annual sales growth for dedicated
cardiac PET & PET/CT scanners, from 35 scanners sold in 2010
to 62 scanners in 2015, or per our estimates, from $26.2
million in 2010 to $46.5 million in 2015.
For many years, a major constraint for this market has
been the high cost of PET and PET/CT scanners for cardiac
studies. Positron has managed to reduce the buyers'
barrier to entry by bringing to market the Attrius; the only
cardiac dedicated PET system in the world. All other
manufacturers (GE, Philips, Siemens) offer PET/CT systems
that have a comparable performance of cardiac studies but
have a 200% to 300% higher price, in relation to the Attrius.
These same PET/CT systems also possess attributes not
optimized or conducive for cardiac imaging. In 2010 and 2011,
Positron's share in sales of dedicated cardiac PET
scanners was 14% and 17%, respectively; we expect growth of
80-90% by 2015. Positron's 2011 sales have been
negatively impacted by the lack of availability of
radiopharmaceuticals. This impact was a result of the
United States Department of Energy (DOE) accelerators limited
availability of supply and by a voluntary recall of
Strontium-82/Rubidium-82 generators from Bracco Diagnostics
for additional testing. With the expected return of
Rubidium-82 and Positron's efforts to increase Strontium
supply, the Company expects up to $9 million in revenue from
Attrius installations in 2012, with an increase to
approximately $44 million in 2015.
Positron estimates the industry's service revenue
at approximately $16.0 million in 2010, which will increase
to $39.0 million in 2015. Positron sells the Attrius scanner
with a 3-5 year service contract. The Company's current
share in annual service revenue is 6-8% and is expected to
grow to 30% by the end of 2015. Positron's annual service
revenue is estimated to be $2 million in 2012, increasing to
$9 million in 2015.
Sales of the primary cardiac PET radiopharmaceutical,
Rb-82, were estimated at approximately $70 million in 2010.
Positron estimates sales to increase to over $200
million in 2015; however, projected revenue is directly
correlated to the availability of Strontium-82 (Sr-82), a
precursor to Rb-82. A limited supply of Sr-82 has and can
compromise the growth rate of cardiac PET. Currently, the
only supplier of Sr-82 in the United States is the US
Department of Energy and the only FDA approved Rubidium-82
supplier in the world is Bracco Diagnostics. This single
supplier environment is where Positron sees great opportunity
and has focused its resources and efforts on acquiring assets
necessary for the vertical integration of the complete value
chain.
Positron has been working on several projects to secure
the supply of Sr-82 and to enter the fast growing market of
PET radiopharmaceuticals. The most significant project is a
70 MeV higher-energy cyclotron that can produce enough Sr-82
to supply Sr-82/Rb-82 generators to current and future
Positron customers, optimally also supplying customers with
the Attrius PET scanners. This is a capital intensive and
long-term project that can eliminate a potential
market-limiting factor in cardiac PET market growth.
Positron, through its subsidiary Manhattan Isotope
Technologies, LLC (MIT), provides expertise necessary to
manufacture process and distribute radioisotopes and
radiopharmaceuticals also providing an immediate-near term
solution to meet the Sr-82/Rb-82 supply. MIT also holds
patented technology and expertise in recycling Sr-82 from
spent generators and has agreements with major foreign
producers. MIT will process and recycle Strontium-82 at its
facilities in Lubbock Texas.
Positron through MIT has additional advantages that we
believe will help resolve a potentially significant problem
that may negatively impact future growth of PET cardiology:
limited waste facilities for spent generators. Currently, the
DOE provides waste management for the spent generators, but
capacity of its waste facilities will reach their limits in
the very near future. MIT has technologies and facilities to
replace the DOE in this role and is currently pursuing this
business.
Positron is currently developing on its own Sr82/Rb82
generator with potential access to 3rd party generators in
the future. Positron is planning to manufacture small
batch PET radioactive products at its cGMP (current Good
Manufacturing Practices) and NRC (Nuclear Regulatory
Commission) licensed facility in Crown Point, Indiana. The
Company has already commenced production of Indium
Oxyquinoline and expects to expand to additional
radiopharmaceuticals and radioisotopes as market demand
occurs. The market for Indium Oxyquinoline is approximately
$30 million in annual domestic sales, and we expect
approximately $2 million revenue in 2012 and to grow annual
sales of the Indium Oxyquinoline to over $10 million through
2015.
PRODUCTS
Positron offers a range of products and services for
nuclear imaging community that are discussed below.
Attrius®
Attrius is the only FDA approved dedicated PET scanner
optimized for cardiac imaging. Attrius was named the
"Most Innovative Device of 2010" by the renowned
business research and consulting firm Frost & Sullivan. The
Attrius provides a robust, cardiac specific imaging software
package designed to ensure effortless interpretation for
today's most challenging clinical cases for nuclear
cardiologists. This innovative software includes coronary
artery overlay display, open architecture for new protocol
development, customization and motion correction and the
ability to monitor therapy. The Attrius is targeted for cardiac
clinics and hospitals and is designed to meet the performance,
budget and space constraints of the most demanding
cardiologists.
Positron achieved significant advancements with the
Company's new state-of-the-art coronary flow reserve
(CFR) software, developed in collaboration with the
University of Texas. Positron expects to offer this software
starting Q3 2012. The CFR software, a clear differentiator
for PET imaging compared to SPECT, was developed by a leading
cardiologist and industry luminary Dr. K. Lance Gould and is
considered to be a key driver in the upcoming growth in
cardiac PET.
PosiStar™
Positron offers a comprehensive world-class clinical,
technical, and service, through the PosiStar customer care
plan. PosiStar includes: 24/7 clinical and service support,
uptime guarantees, remote access diagnostic/maintenance,
physician interpretation training, billing training; nurse
training, post-install physician over-reads, ICANL approval
assistance, 6 months evaluation/assessment, industry luminary
collaboration and more. PosiStar is an annual fee-based
contract, typically for three to five years.
PosiRx™
PosiRx is a radiopharmaceutical system that automates the
elution, preparation, and dispensing processes for
radiopharmaceutical agents used in SPECT imaging. It was
created to simplify and control the procedures associated with
compounding radiopharmaceuticals. PosiRx is the first
system of its kind to offer a complete and comprehensive
automated solution in Nuclear Medicine; creating a more
efficient and economical alternative to the current pharmacy
per dose model. A nuclear cardiology facility equipped with
PosiRx has 24/7 unit dose accessibility with the reliability of
an on-site supply eliminating the need for scheduled deliveries
of unit doses from centralized radiopharmacies. A
self-contained device, the PosiRx is compliant with U.S.
Pharmacopoeia regulations. The USP 797 regulation governs any
pharmacy that prepares "compounded sterile
preparations". Positron's proprietary automated
quality control module for the PosiRx system includes a patent
pending method of testing Tc-99m compounds for radiochemical
purity. PosiRx is targeted for cardiac clinics and hospitals
with an average to high SPECT imaging volumes
Positron's PosiRx has completed validation testing
and is being marketed to leading nuclear cardiology
luminaries and nuclear pharmacies. To best serve market
needs, Positron intends to offer different revenue
models: rent/sell and service PosiRx systems to
practices/hospitals handling their own radiopharmaceutical
consumables, and/or sell radiopharmaceutical consumables
directly to practices/hospitals through installed PosiRx
systems.
RADIOPHARMACEUTICALS
Manufacturing
Positron commenced production of Indium Oxyquinoline at
its cGMP (current Good Manufacturing Practices) facility in
Indiana and intends to file an aNDA for FDA approval to market
and sell radiopharmaceuticals directly to physicians. Positron
has radiopharmacy customers for radiochemical grade Indium.
Positron entered into the Indium market, projecting an
increased demand in an underserved market and as a precursor
for its PET radiopharmaceuticals initiatives.
Rb-82 Generator
The Company accelerated development of a proprietary
Rb-82 generator and its associated infusion cart with
prototypes currently in the testing phase. This product is a
key element of Positron's strategy to vertically integrate
the production and delivery of a complete cardiac imaging
solution: isotope (Sr-82), generator (Rb-82), and imaging
system (Attrius).
ISOTOPE PRODUCTION
70MeV Cyclotron
Positron Corporation intends to build and operate a
high-energy cyclotron facility to be used primarily for the
production of medical isotopes for PET diagnostic imaging and
radiotherapy. The proposed facility will be equipped with a
70MeV cyclotron and be unique in that it will be capable of
producing isotopes that are not available, or very limited
availability, from other commercial sources in the United
States and the world. Positron intends to combine the cyclotron
with a material processing facility, isotope target
manufacturing, drug manufacturing and equipment-manufacturing
expansion plans.
Sr-82 is the primary isotope to be produced, currently
in short supply throughout the world and only produced in the
U.S. by the DOE National Laboratories. It is the policy of
the DOE not to compete with the private sector, therefore can
be compelled, via petition, to withdraw from the market when
materials are reasonably available commercially. This
policy may play an important role in the future availability
of Sr-82 supply.
Strontium is the parent isotope for producing Rb-82 in
Sr82/Rb82 generators utilized in PET myocardial perfusion
imaging. Positron is currently developing its own generator
and intends to purchase all Sr-82 produced by the cyclotron
facility to supply its cardiac PET client base. The access to
Rb-82 generator(s) would allow Positron to have a completely
integrated value chain that includes radioisotope production,
radiopharmaceutical manufacturing and distribution.
The cost of the project, including equipment, building,
land, working capital and contingencies, is approximately $64
million. Positron executed an agreement with IBA Molecular,
of Belgium, to manufacture a 70 MeV cyclotron and has
contracted a leading engineering and architecture firm to
design the facility. The facility will be located in
the city of Noblesville, Indiana, concurrent with the
relocation of Positron's corporate headquarters and
manufacturing. The facility will take approximately 36 months
to build. The Company expects to begin isotope production &
operations in 2015.
In July 2011, Noblesville City Council approved to
provide Positron $6.7 million in economic incentives through
the issuance of long-term Economic Development Tax Increment
Revenue Bonds. In September 2011, the Indiana Economic
Development Corporation awarded $38 million of tax-exempt
Midwestern Disaster Area Bonds to Positron
Corporation.
This 70 MeV cyclotron project is planned to be executed
through a wholly owned subsidiary, Positron Isotopes
Corporation. Positron Isotopes Corporation is expecting to
raise equity from the sale of its capital stock with a
portion to be loaned to Positron Corporation for further
development of the market for PET radiopharmaceuticals and
high-energy medical isotopes. Positron Isotopes Corporation
shares, held by Positron Corporation, will secure the loan.
Once the project is completed, the estimated consolidated
revenue for Positron Corporation from radiopharmaceuticals
and radioisotopes from Positron Isotopes Corporation is
approximately $120 million per year.
Manhattan Isotope Technology, LLC
Manhattan Isotope Technology, LLC (MIT) is a wholly owned
subsidiary of Positron Corporation. MIT provides expertise
necessary to manufacture process and distribute radioisotopes
and radiopharmaceuticals also providing an immediate-near term
solution to meet the Sr-82/Rb-82 supply. MIT also holds
patented technology and expertise in recycling Sr-82 from spent
generators and has agreements and/or relationships with the
major foreign producers. MIT will process and recycle
Strontium-82 at its facilities in Lubbock Texas.
Founded in 2009 by former Los Alamos National
Laboratories (LANL) scientists, MIT personnel were at the
core of the DOE team that provided the majority of the
world's Sr-82 supply over the past 15 years, which also
developed patented technology for recycling Sr-82 from
expired Sr-82/Rb-82 generators. This patented recycling
production method was exclusively licensed to MIT from the
DOE via Los Alamos National Laboratory in 2010.
MIT is the only commercial resource in the United
States with practical knowledge and experience in all stages
of Strontium-82 production. Its current facility in Lubbock,
Texas, has the capacity to provide critical services
necessary for the refurbishment of spent
Strontium-82/Rubidium-82 generators and the recycling of
Strontium-82 using patented methods. Over the past five years
the explosive growth of PET imaging has driven a significant
increase in the Sr-82/Rb-82 generator demand, creating an
environment whereby the Sr-82 demand has begun to outpace
supply. MIT intends to focus on increasing the Active
Pharmaceutical Ingredient (API) Sr-82 supply through
recycling Sr-82 from spent generators and production of Sr-82
from foreign suppliers. MIT also brings singular expertise in
the production of many other radioisotopes, such as
germanium-68, which have no commercial supply in the US
besides the US government.
MIT, with the support of Positron, has executed a
Memorandum of Understanding with the ARRONAX Cyclotron
Facility in Nantes, France. ARRONAX is one of a small number
of global accelerator facilities that possess the requisite
proton beam characteristics for Strontium-82 production. MIT
and ARRONAX will collaborate on the production of
Strontium-82 and other medical radionuclides, such as
Germanium-68. The collaboration of ARRONAX and MIT will
expand the global supply of Sr-82, a supply that is very
limited and in great demand by the medical community.
MIT expects Sr-82 validation samples to begin arriving
from ARRONAX at the Lubbock, Texas processing facility in
early 2012 followed by MIT's filing of a Drug Master File
with the US FDA to be completed spring of 2012. Currently,
the US Department of Energy is the only supplier of API grade
Strontium-82 in the United States.
MIT expects to generate approximately $2 million in
sales from the refurbishment and recycling of Sr-82/Rb-82
spent generators during the first year of operation, with a
20% annual growth thereafter. Depending on availability
additional annual revenue of $5-10 million can be expected
from production of Sr-82 from foreign suppliers.
MIT delivers significant value to the Company by
providing a credible and viable radioisotope processing plan,
access to existing domestic and foreign isotope supply,
supply chain management, and radioactive waste solutions. MIT
has the intellectual property, expertise and facilities
needed to accelerate Positron's plans for securing the
supply channel and becoming a leader in Sr-82 supply thereby
offering a full PET solution for the nuclear cardiology
industry.
Positron Looking Forward to 2012
The year 2011 was a very dynamic and strategic year for
Positron. The Company's revenue increased to approximately
$7 million; however, our growth was hindered by the limited
availability of consumables. Due to the explosive growth in
cardiac PET imaging, the radiopharmaceutical market was highly
stressed. Although the industry experienced its most
challenging year ever, it truly was an advantage in the best
interest of Positron as it enabled the Company to aggressively
execute its strategy to aggregate and assimilate the key
components that are critical to securing its supply chain and
position Positron as a complete cardiac imaging full solutions
provider. If we are successful in our execution, Positron will
have all the necessary elements integrated into a complete
supply chain: securing radioisotopes -processing radioisotopes
- manufacturing radiopharmaceutical(s) - generators - PET
systems - services; at a time when the industry is seeking
leadership to meet the growing demand.
We believe that the Company's efforts will have an
immediate impact in our business and begin to deliver
tangible returns in 2012:
// Attrius sales are expected to resume with the return
of Rubidium-82 generators to the market. We
believe the
market will further expand as the potential of new generator
manufactures emerge.
// Positron (MIT) intends to begin recycling spent
generators, further increasing the availability of
radiopharmaceutical
supply.
// Positron (MIT) will begin processing Sr-82 through
relationships with foreign and domestic suppliers.
// Positron's radiopharmaceutical manufacturing
facility will produce pharmaceuticals and expand to
additional
pharmaceutical/isotope products.
// PosiRx installs are expected to accelerate through
affiliations with GPO's and radiopharmaceutical
companies. The
Company will seek expansion opportunities into emerging
markets.
// Positron expects financing and project launch of its
high-energy 70 MeV cyclotron project thereby securing
supply
for its future growth.
// Positron projects 100% growth in revenue to $15
million in 2012 with comparable growth for following
years
through 2015 when the cyclotron project is
operational.
Positron as an Opportunity
By offering innovative products and services, Positron
has methodically positioned itself as the industry's only
complete cardiac imaging solutions provider. Through this
approach, Positron will be able to significantly reduce supply
chain costs and uncertainties, passing on the rewards to its
customers.
Positron has significant potential earnings power.
Projected revenue growth could be exponential over many
years, increasing as each of our components become available.
The cardiac imaging industry has an indisputable need for a
full solutions provider with the vision to aggregate all key
components to meet the increasing demands of the market.
Execution of our plans will strengthen Positron's
position as a major player in the field of nuclear medicine
and well help secure a profitable future for all invested
parties.
PET is the future of nuclear cardiology. Positron is
PET.
Forward Looking Statements:
Statements in this document contain certain
forward-looking statements within the meaning of Section 27A of
the Securities Act of 1933 and Section 21E of the Securities
Exchange Act of 1934, as amended. These statements are based on
many assumptions and estimates and are not guarantees of future
performance. These statements may involve known and unknown
risks, uncertainties and other factors which may cause the
actual results, performance or achievements of Positron
Corporation to be materially different from future results,
performance or achievements expressed or implied by such
forward-looking statements. Positron assumes no obligation to
publicly update or revise these forward-looking statements for
any reason, or to update the reasons actual results could
differ materially from those anticipated in these
forward-looking statements, even if new information becomes
available in the future. Our actual results may differ
materially from the results anticipated in these
forward-looking statements due to a variety of factors,
including, without limitation those set forth as "Risk
Factors" in our filings with the Securities and Exchange
Commission.