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Vasogen Inc. AMEX:
MEW BUY RECOMMENDATION - Terry L. Stein Analyst
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Date of Report:
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Dec. 7, 1999
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Shares Outstanding:
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35.0 M
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EPS (C$)
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P/E
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| Stock Price: |
$4.13
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Estimated Float: |
10.0 M
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1998A ($0.29)
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-
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| 12 mo. Price Range: |
$0.69 - $4.81
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Recommendation: |
Buy
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1999E ($0.20)
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-
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| Industry Sector: |
Medical Device
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12-18 mo.Target Price: |
US $7.66
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2000E ($0.01)
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-
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| 30-day Avg. Daily Vol. |
25,000
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Est. 5-Yr. EPS Growth: |
33%
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2001E $0.20
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20X
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BASIS FOR RECOMMENDATION
o Vasogen is focused on large and growing segments of
the healthcare market and offers the investor an excellent opportunity
to participate in the growth of this industry and the Company.
o Vasogen has assembled a capable and experienced management team
with the expertise to guide the Company's research and development
programs and to execute its business development strategy.
o Vasogen's medical device classification will allow the Company to
bring products to market significantly faster than traditional pharmaceutical-based
alternatives.
o Vasogen has a strong product pipeline to support long-term growth.
With several products in clinical trials, the Company has four separate
licensing opportunities that we believe should come to fruition over
the next 18 months.
o Vasogen's promising pre-clinical and clinical results should lead
to near-term revenues. Relative to available drug therapies and surgical
interventions, the Company's therapies offer the potential for a safer,
less expensive, and more effective treatment for a number of major
disease states.
THE COMPANY
Vasogen is a Toronto-based biotechnology company focused
on the development and commercialization of immune modulation therapies
for the treatment and prevention of cardiovascular, autoimmune and
related inflammatory diseases. Within the last few years, immunology
has undergone a radical change in terms of scientific thinking. New
discoveries concerning how the human immune system functions have
led to rapidly changing ideas regarding possible treatments for immune-related
diseases. Vasogen's immune modulation therapies are on the leading
edge of this new knowledge.
Vasogen has developed a series of immune modulation
therapies based on its proprietary platform medical device technology:
o VASCare?tm; therapy, for the prevention and treatment
of atherosclerosis and related cardiovascular disease, is in the
late stages of a multi-center double blind clinical trial in the
U.K. in patients with peripheral vascular disease, a serious form
of cardiovascular disease. Researchers at the University of Toronto
have shown in pre-clinical research that VasoCare therapy
can reduce the progression of atherosclerosis by up to 75%.
o VAS971, designed to protect multiple organs from the damaging
effects of ischemia/reperfusion injury (injury due to interruption
of blood flow) during major surgery or as a consequence of heart
attack or stroke, has recently received U.S. FDA approval to enter
clinical trials at Baylor College of Medicine, one of the world's
leading cardiovascular surgery centers. Ischemia/reperfusion injury
causes significant mortality and morbidity in the >500,000 cardiovascular
surgeries performed each year in the U.S.
o VAS972, for the treatment of autoimmune disease, is currently
in a clinical trial in psoriasis patients at the Sunnybrook Health
Sciences Center, University of Toronto. This trial is based on recent
pre-clinical results in a model of an inflammatory skin condition
that were comparable to those seen with cyclosporine (the current
drug of choice for treating moderate to severe psoriasis) without
its toxic side effects. Autoimmune diseases, such as psoriasis and
rheumatoid arthritis, affect over 80 million people worldwide.
o VAS981 is being developed for the prevention of Graft-versus-Host
Disease-a life-threatening complication of bone marrow transplantation.
VAS981 is expected to be approved for clinical trials in cancer
patients by the end of the year. In pre-clinical research, VAS981
has been shown to prevent Graft-versus-Host Disease.
The Company's shares recently began trading on the American
Stock Exchange (AMEX:MEW), in addition to the Toronto Stock Exchange
(TSE:VAS). Recent events, such as the announcement of FDA approval
to begin clinical trials of the Company's VAS971 product at Baylor
College of Medicine in Houston, Health Canada approval to proceed
with clinical trials in psoriasis, and positive results from human
clinical trials of the VasoCare product in atherosclerosis,
have produced increased interest and trading in the Company's stock
among U.S. investors. Vasogen already has strong liquidity on the
TSE. We believe that broader awareness in the U.S. of Vasogen's significant
potential will serve to provide the Company with a growing investor
base, along with solid liquidity going forward.
Vasogen has assembled a management team consisting of experienced
and respected professionals with the necessary expertise to carry
out the Company's business plan and achieve corporate revenue goals.
The Company recently strengthened its Board of Directors with the
addition of several U.S. healthcare executives who have proven track
records in the management and growth of medical product businesses.
In addition to providing Vasogen with the expertise and guidance to
successfully commercialize its products, we believe that this team
gives investors the confidence they need to remain loyal. With strength
in management and at the board level, we feel that Vasogen is well
positioned to take full advantage of the streamlined medical device
regulatory approval process and rapidly move its products to market.
The Company's products will be marketed through licensing agreements
with large, well-established marketing partners. Vasogen is well capitalized
with the funds to carry out its business plan through Q3 2001 and
the execution of its strategy is not contingent upon large infusions
of capital.
INDUSTRY
There is one consistent theme inherent in Vasogen's
technologies: the Company's immune modulation therapies have the potential
to provide the healthcare industry with a less expensive treatment
for a number of major diseases, providing attractive margins to Vasogen
and its marketing partners, and, at the same time, helping to reduce
costs to managed care providers. We expect Vasogen's safe, cost-effective
therapies, once clinically developed, to be extremely attractive to
patients, healthcare providers and medical insurers.
To understand the Company's research and development strategy, one
must understand the medical areas in which Vasogen participates. The
following provides a general overview of the industry sectors for
which the Company's products will provide solutions to current unmet
needs.
Cardiovascular Disease
Vasogen's immune modulation therapy, VasoCare
therapy, is being developed for the treatment and prevention of cardiovascular
disease. The major cause of cardiovascular disease, atherosclerosis,
or "hardening of the arteries", is characterized by the
build-up of cholesterol-containing plaque within the blood vessel
wall. It is a well recognized fact that cardiovascular disease (CVD),
including heart attack, stroke, and peripheral vascular disease, is
and will continue to be the number one cause of death in the developed
world. The disease affects nearly 59 million Americans and results
in over $286 billion in annual healthcare costs. Coronary Heart Disease
(CHD), a subset of CVD, claims over 500,000 lives in the U.S. every
year, with treatment costs and lost wages estimated between $50 and
$100 billion annually.
As the largest segment of the population, the "Baby Boomers",
enter the age group most in need of CVD-related medical treatments,
the number of CVD patients is expected to increase sharply. This increase
is also fuelled by societal trends, such as increasing obesity, sedentary
lifestyles, and poor dietary habits. This rise in the number of treatments
and procedures necessary to serve this growing market will necessitate
the development of safer and more cost-effective treatments that will
reduce the need for expensive hospitalization and, when hospitalization
is necessary, shorten hospital stays. Cost containment within the
healthcare and insurance industry will be the driving factor as the
industry searches for ways to maintain profit margins, while meeting
the increasing demands of patients and payers.
Ischemia/Reperfusion Injury
Vasogen's cytoprotective immune modulation therapy,
VAS971, is being developed for use in major vascular surgical procedures
and could also be used in patients at risk of heart attack or stroke.
When blood flow to the various organs in the human body is interrupted
and then restored, as is observed with heart attacks, strokes and
major vascular surgical procedures, there is an immune-mediated inflammatory
response, known as ischemia/reperfusion (I/R) injury, which can lead
to severe tissue damage. I/R injury is marked by an increase in programmed
cell death, known as apoptosis. The effects of this response present
many complications and take a tremendous toll on the patient.
Each year, it is estimated that more than one million patients will
undergo major vascular surgical procedures, such as aneurysm repair
surgeries and coronary artery bypass graft surgeries. As the population
ages, surgical procedures of this type are expected to increase. As
a result, healthcare companies, third party insurers, and managed
care organizations will demand the development of treatments to improve
the outcome of these surgical procedures. We feel that Vasogen's VAS971
has the potential to address these complications and thereby provide
a solution to one of the major problems confronting the medical industry.
By improving the outcome of these types of surgeries and by reducing
the associated complications, this should lead to upwards of $1 billion
in annual cost savings to the healthcare system as a result of fewer
post-operative complications and shorter in-patient hospital stays.
Autoimmune Diseases
Vasogen's immune modulation therapy, VAS972, is being
developed for the treatment and prevention of autoimmune diseases,
initially targeting psoriasis and rheumatoid arthritis. There are
some 80 conditions classified as autoimmune disorders, such as rheumatoid
arthritis, psoriasis, and multiple sclerosis. According to the American
Autoimmune Related Diseases Association, as many as 50 million Americans
suffer from some form of autoimmune disease. Dr. Noel Rose, a Johns
Hopkins University expert, estimates that autoimmune conditions cost
$87 billion a year in healthcare expenditures. Psoriasis, one of the
most prevalent autoimmune diseases, affects upwards of 2% of the world's
population according to the World Health Organization. In the U.S.
alone, it is estimated that 200,000 new cases are reported each year.
The costs of treatment and care exceed $3 billion dollars annually.
Graft-Versus-Host Disease (GvHD).
Vasogen's VAS981 is being developed for the treatment of donor bone
marrow during the bone marrow transplantation procedure to prevent
Graft-versus-Host Disease (GvHD). Bone marrow transplants have been
a very effective form of treatment for patients with certain types
of cancer, such as leukemia and lymphoma. However, due to the risk
of GvHD, their use has been severely limited by a lack of suitable
donors.
GvHD results from a less than perfect donor/recipient tissue match.
GvHD can be a serious and life-threatening condition when T-cells
in a donor's bone marrow react against the genetic differences in
the patient. This can cause a range of serious complications, including
infection, organ failure, and death.
Although there are drugs currently available that suppresses the immune
system and can reduce the severity of this problem, GvHD remains a
major cause of death in bone marrow transplant patients. The complications
associated with GvHD are estimated to cost the healthcare industry
in excess of $400 million annually. A successful treatment for GvHD
could vastly increase the number of bone marrow transplants performed
annually for current uses and broaden the use of bone marrow transplants
to additional applications.
PRODUCTS
Vital to Vasogen's success is the ability to develop
products and introduce them into the marketplace. Currently, the Company
has a pipeline of four immune modulation therapies that have passed
various levels of pre-clinical and clinical development. If the ongoing
clinical trials proceed as planned, and demonstrate that Vasogen's
products offer both a safe and effective treatment, the Company would
be in an excellent position to attract major, multinational marketing
partners and generate significant revenues through up-front licensing
fees and royalties on sales.
Vasogen's immune modulation therapies involve treatment of a patient
by the administration of a small sample of the patient's own immune
cells that has been modified by brief exposure to physicochemical
processing. Following administration of the modified sample, the recipient's
immune system reacts against the modified immune cells, with the ultimate
effect being a down-regulation of pro-inflammatory auto-reactive immune
cells, resulting in lower levels of inflammation, less tissue damage,
and a reduction in disease. Research shows that the modified immune
cells elicit an immune response that restores the immune system to
a balanced state.
An immune system that is out of normal balance is believed to be the
underlying cause of many immune related diseases, including autoimmune
diseases such as rheumatoid arthritis, multiple sclerosis, and psoriasis,
and those with an autoimmune inflammatory component, such as atherosclerosis
and ischemia/reperfusion injury. The prevention and treatment of conditions
such as these is the basis of Vasogen's therapeutic approach.
Platform Medical Device Delivery Technology
Vasogen's immune modulation therapies are administered
using a low cost, proprietary platform medical device technology that
includes a compact self-calibrating medical instrument and a single-use
disposable. The delivery of a course of immune modulation therapy
involves three 20-minute outpatient treatments administered over a
two-week period. A single treatment involves the withdrawal of a sample
of blood from the patient, modification of the immune cells within
the sample, and administration of the sample to the patient.
Revenues will be generated by Vasogen on the sale of therapeutic sessions,
each of which requires a single-use disposable and a unique treatment
card which enables the delivery of a single course of therapy.
VasoCare: Therapy: Treatment and Prevention of Cardiovascular
Disease.
Vasogen is developing VasoCare, an immune modulation
therapy that targets the underlying disease process of cardiovascular
disease-atherosclerosis (hardening of the arteries). This approach
is expected to lead to a more effective and lower-cost treatment option
relative to current therapies.
VasoCare therapy is in late-stage clinical trials at two leading
research centers in the U.K., targeting peripheral vascular disease
(PVD). PVD results from atherosclerotic obstruction of arteries leading
to the extremities causing restricted blood flow to the legs and feet.
A common symptom of PVD, pain when walking, is the internationally
accepted gauge to assess the effectiveness of new treatments. So far,
the most promising drug treatments have had limited success; walking
distances have increased by only 40% and most treatments have adverse
side effects. A feasibility study of VasoCare therapy in PVD,
conducted to support the current U.K. trial, has already shown a 93%
average increase in pain-free walking distance and no significant
adverse side effects.
Vasogen recently announced the results from a placebo-controlled,
double blind clinical trial of VasoCare therapy in PVD, conducted
at the University Hospital in Lund, Sweden. In patients receiving
VasoCare therapy, there was a significantly improved rate of
recovery of skin blood flow following ischemia as compared with baseline,
whereas in the placebo group there was no significant change. These
results provide the first important link between pre-clinical results,
where VasoCare therapy has been shown to reduce the development
of atherosclerosis by up to 75%, and the clinical treatment of PVD,
where a therapy with this ability would be a major breakthrough.
Based on clinical trials completed to-date, the VasoCare product
has already received regulatory approval in Europe where, as in North
America, it is classified as a medical device. VasoCare therapy
clinical trials could be completed in the U.K. as soon as Q3 of 2000
and the therapy would be ready to be marketed in Europe by the end
of 2000.
VAS971: Prevention of Organ Damage Due to Ischemia/Reperfusion
Injury
VAS971 is Vasogen's lead product in the United States
and was developed to prevent ischemia/reperfusion (I/R) injury. I/R
injury is a major cause of tissue damage and death that occurs when
blood flow to an organ is interrupted and then later re-established.
Situations where I/R injury may occur include heart attacks, strokes,
and during major vascular surgery. In pre-clinical studies, the ability
of VAS971 to protect multiple organs against I/R injury has been clearly
demonstrated.
The first clinical trial of VAS971 is now underway at Baylor College
of Medicine in Houston, Texas, one of the leading vascular surgery
centers in the world. This trial is focusing on the ability of VAS971
to prevent I/R injury during thoracic aortic aneurysm (TAA) repair
surgery, a form of vascular surgery that carries one of the highest
risks of I/R related complications and death (42% morbidity; 7% mortality).
Success in this surgery would lead to applications of the therapy
in abdominal aortic aneurysm (AAA) surgery and coronary artery bypass
graft (CABG) surgery where the market exceeds 500,000 procedures annually
in the U.S. alone.
Provided the Baylor trials are successful, we expect VAS971 to attract
many suitors for partnering and licensing arrangements.
VAS972: Treatment and Prevention of Autoimmune Disease
Vasogen's VAS972 immune modulation therapy has shown
considerable promise as a treatment for autoimmune disease. A variety
of autoimmune diseases, including rheumatoid arthritis, multiple sclerosis,
and psoriasis, develop when a person's own immune system attacks his
or her own tissues. The immune system is designed to protect the human
body from invading microorganisms by producing antibodies and activating
white blood cells. Normally, these immune cells only attack invading
microorganisms. It is possible, however, for these cells to become
misdirected and attack the very cells that they are meant to protect,
leading to autoimmune disease.
In a pre-clinical model of inflammatory skin disease, VAS972 demonstrated
effectiveness comparable to that of commonly prescribed immunosuppressive
drugs such as cyclosporine, but without their serious side effects.
On the strength of these findings, Vasogen recently received regulatory
approval to proceed with clinical trials of VAS972 for the treatment
of psoriasis, a common and often serious autoimmune disease affecting
the skin. These trials are being conducted at the Sunnybrook Health
Sciences Center, University of Toronto, one of the largest psoriasis
treatment centers in North America. Clinical results in psoriasis
are expected in the middle of 2000.
VAS981: Prevention of Graft-Versus-Host Disease (GvHD)
The prevention of GvHD with VAS981 has proven successful
in pre-clinical studies. Vasogen expects to begin human clinical trials
in cancer patients at the University of Toronto in Q1 2000. Should
the treatment prove successful, fast-track regulatory approval would
be expected in the United States, Canada, and Europe. VAS981 would
initially be targeted at patients with cancers of the blood (leukemia/lymphoma)
who could potentially be cured by a bone marrow transplant.
The ability to prevent GvHD in human patients would represent an opportunity
for Vasogen's VAS981 product to extend the use of bone marrow transplantation
to mismatched donors and recipients. We believe this could double
the number of bone marrow transplants performed each year, greatly
expanding the market for VAS981.
MARKETING STRATEGY
Vasogen's products are classified as medical devices,
which is an extremely favorable regulatory classification when compared
to the costly and time-consuming pharmaceutical regulatory approval
process. Vasogen plans to license the marketing and distribution rights
for their proprietary therapies to strategic healthcare partners who
will pay fees and royalties to Vasogen.
To support this licensing strategy, Vasogen has applied for and received
patent protection for their products. This patent protection currently
includes all aspects of the Company's therapies, including the delivery
technology, immune cell treatment processes, bone marrow treatment
processes, and application of these therapies to a broad range of
related diseases. Vasogen has been granted five patents and has another
twelve patents pending.
MARKET DYNAMICS
The opportunities in the therapeutic sector represent
potentially huge profit potential. As an example of the potential
in this sector, a recent research report published by Bear Stearns
stated that the market for therapeutics and devices associated with
abdominal aortic aneurysm repair alone is expected to reach $2 billion
in the near future. The specialty medical device and pharmaceutical
sectors have not only opened the eyes of many key multinational players,
but also offer extremely lucrative areas in which Vasogen can participate.
COMPETITION
The healthcare market is intensely competitive, with
a large number of firms of all sizes, stages and levels, developing
therapies for many types of disease. While at a macro level Vasogen
has a vast competitive field to face, the Company's products have
a number of competitive advantages. These include an excellent safety
profile, cost-effective delivery and long-lasting therapeutic benefits.
There are several companies that are focused on modulating the immune
system to treat autoimmune disease, and hence may be considered to
be competitors of Vasogen. These companies have a broad spectrum of
products as does Vasogen and some have entered into partnerships with
larger pharmaceutical firms. We feel that Vasogen will follow suit
by attracting similar partners.
FINANCIAL INFORMATION
The Company's shares trade on the American Stock Exchange
(AMEX) under symbol MEW and on the Toronto Stock Exchange (TSE) under
symbol VAS, with most of the trading volume to date occurring on the
TSE, providing solid liquidity for global investors. In addition,
Vasogen is widely held by blue-chip, institutional shareholders who
currently hold approximately 40% of the outstanding common stock,
with insiders holding 15% on a fully diluted basis. The Company is
a full reporting issuer in the U.S. and reconciles its financial statements
to U.S. GAAP.
The Company is in the development stage, and therefore has no revenue
or earnings. Financially, however, Vasogen does not fit the typical
biotech mold. The Company's cash reserves will likely carry it through
to positive cash flow, subject to the completion of its planned clinical
trials and regulatory approval processes, and the conclusion of initial
marketing partnerships.
OUTLOOK/VALUATION
Although any one of the products in Vasogen's pipeline
has the potential to become a huge revenue generator, the Company
has yet to derive revenues from these products. Because Vasogen is
not dependent on any one product for the firm's success, each of the
targeted markets is quite large, and the Company is in the relatively
late stages of the regulatory process for each of its therapies, we
feel confident that the Company will reach our revenue projections.
Due to the fact that biotechnology companies lack revenues at this
stage of development, it is often difficult to arrive at a model to
determine a fair share value. Typical valuation models for development
stage companies use such methodologies as discounted cash flow, market
capitalization comparisons with companies of comparable size and scope,
and price/earning multiples as a guide to valuation.
In order to provide a valuation for Vasogen that is as fair and accurate
as possible, we have used a valuation methodology that reflects not
only a fundamental, but also a technical approach. We screened our
database for all biotech companies of like size and scope of products,
retaining only those which closely matched Vasogen. By using our valuation
model to compare Vasogen to other companies of similar size and scope,
we achieved what we believe to be a fair valuation for Vasogen. We
found that similar companies had an average price to cash/flow multiple
of 37x. Using Vasogen's C$0.24 per share (Primary-2001E) we arrived
at a valuation of C$8.88, which corresponds to an adjusted US$5.95
(approximate) per share valuation for Vasogen, based on current exchange
rates. Adding to this we also chose to balance this valuation with
a market capitalization comparison. For the stocks of comparable companies
listed in the table below, we arrived at an average market cap of
$328 million dollars, or US $9.37 per share average. We feel that
should Vasogen's products prove effective and cost efficient, the
company's market cap would rise to the average level of their competitors.
By using the average of these two valuations we arrive at our target
price of US $7.66.
The following table lists therapeutics companies comparable in size
and scope to Vasogen:
Company Symbol Market Cap
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Company
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Symbol
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Market Cap
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Corixa
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CRXA
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$ 235 million
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Avant Immunotherapeutics
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AVAN
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$ 100 million
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CV Therapeutics
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CVTX
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$ 156 million
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LeukoSite, Inc.
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LKST
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$ 406 million
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Abgenix Inc.
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ABGX
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$ 745 million
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Vasogen Inc.
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VAS/MEW
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$ 140 million
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On a technical basis we feel that Vasogen's stock has entered an accumulation
phase and that further price appreciation may be caused by continued
news announcements. Companies like Vasogen do not always follow traditional
fundamental valuation considerations and therefore are often subject
to the fancy of the market's view of the industry sector. Many times
the announcement of regulatory approvals and signed partnership contracts
cause these types of companies to become "discovered" and
their respective stock values to appreciate substantially. We feel
investors who are willing to accept the hi.
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