THE STEWART REPORT
HOTLINE SUMMARY
Special Report: Amarillo Biosciences, Inc.
Wednesday, June 1, 2005
(Next HotLine Scheduled for Wednesday, June 29, 2005)
Instead of “Amarillo Biosciences, Inc.,” the headline
for this Special Report could just as easily read: “Good
Company, Inc.”
After all, that’s what we own – shares in one very Good
Company, which is itself in very “Good Company”
judging by the distinguished professionals and scientists both on
the stockholder list and in attendance at the shareholder meeting.
At the top of this list, of course, is Hayashibara Biochemical Laboratories.
This giant Japanese pharmaceutical company has invested more than
$16.5 million in our tiny Texas biotech over the years, and now owns
20.5 percent of all Amarillo shares outstanding. Several score of
Amarillo’s roughly 1,400 stockholders of record are also scientific
professionals employed by Hayashibara - including Mr. Hayashibara
himself.
On the geographic flip-side, many more of those 1,400 or so Amarillo
Biosciences shareholders are themselves Amarillo area scientists
- to wit, Texas doctors or researchers practicing either human or
veterinary medicine. Indeed, at least eight of those medical pros
were in the audience on Friday, May 27, when Amarillo Biosciences,
Inc. (Nasdaq/BB: AMAR – $0.35), hosted its annual shareholder
meeting.
As I promised in the last HotLine, The Stewart Report’s proxy
at that meeting – by virtue of actually living in Amarillo –
was our Editor-in-Chief, Larry D. Spears. Larry’s observations
from that morning’s event have been incorporated throughout
this evening’s document, while some of his same-day notes have
been quoted directly, as follows:
“AMAR President, CEO and CFO Dr. Joseph Cummins opened the
meeting by introducing each of the nine non-corporate officers in
attendance, all but one of whom he knew personally by virtue of their
long-term tenure as shareholders. Worth noting, seven of those nine
were doctors of either human or veterinary medicine – again
strong and vested testimony to the health profession’s belief
in the value of Amarillo’s low-dose oral interferon in both
treating and preventing various human ailments and animal maladies.
“Later, while ballots and proxies were being tallied for the
election of the corporate board of directors and other official items
of business, attendees received briefings on two new studies the company
is preparing to undertake, as well as three studies or clinical trials
currently underway. The two new projects are:
• A program in conjunction with Ohio State University funded
under a $104,372 grant from the National Institutes of Health (NIH)
to treat gnotobiotic piglets for h. pylori bacteria, a leading cause
of gastric ailments in humans. If the pig trials prove effective,
it could lead to future studies of interferon alpha efficacy against
gastritis and gastroduodenal ulcers in humans.
• A journey by AMAR representatives to Cambodia in July to assist
in setting up a study to evaluate whether oral interferon regimens
can be used in treating or preventing the growing outbreak of Avian
flu in Southeast Asia. World health officials have expressed extreme
fears about the potential threat of a pandemic arising from the so-called
“bird flu.” Amarillo is hopeful oral interferon may prove
to be both a practical and cost-effective treatment option, based
on results of Russian tests of interferon in the1960s to treat Hong
Kong flu.
“As for projects currently in progress:
• A joint 12-week study with Nobel ILAC in Turkey to evaluate
interferon treatment of 90 patients suffering from Behçet’s
disease. Behçet’s is relatively rare in the U.S., with
under 15,000 cases, but is much more prevalent in the Middle East.
Thus the focus on Turkey, which has an estimated 260,000 Behçet’s
sufferers.
A study in conjunction with M.D. Anderson Cancer Center in Houston
to test the efficacy of oral interferon in treating two different
myeloproliferative diseases – polycythemia vera and essential
thrombocythemia.
These diseases impact the body’s ability to fight blood clots
and, in the case of the latter, may lead to development of leukemia.
Current treatments are only marginally effective and involve significant
harmful side effects. Each study group will consist of 20 patients,
and positive results could lead to further trials, as well as application
for orphan-drug designation for interferon treatments. (The two diseases
affect 7,000 to 8,000 new patients per year.)
• A study being conducted by Dr. Lorenz Lutherer of Texas Tech
(who presented his results at the meeting) to treat sufferers of idiopathic
pulmonary fibrosis, a degenerative lung disease that is nearly always
fatal within three to five years of diagnosis.
The study has been underway for more than three years and has shown
positive results in arresting the progression of the disease, though
no evidence has been shown that it can either cure or reverse its
effects. Additional test patients are still being sought for this
study, and AMAR hopes to do more work on the disease in conjunction
with the national Pulmonary Fibrosis Association, as well as applying
for orphan-drug status. (There are roughly 80,000 patients in the
United States.)
“While none of these studies has yet reached a stage where
they generate revenues for the company, Amarillo benefits because
other entities are bearing the bulk of the study costs. Using a cost
assumption of $10,000 per patient, the four studies cited thus represent
roughly $1.6 million in “free” research evaluating Amarillo’s
intellectual properties and patents. Worth noting, the company currently
owns or licenses 16 separate U.S. patents on the medical and veterinary
use of oral interferon alpha. This additional funding could very easily
add to these already considerable assets – and, again, we’re
using other people’s money.
“Dr. Cummins also announced receipt of some new revenues as
an outgrowth of the company’s Hayashibara relationship. AMAR
received its first royalty check from BioVet, Inc., a Tokyo-based
veterinary medicine company that has obtained regulatory approval
to use Amarillo’s interferon formula to treat calves for rotavirus.
The check, which totaled $40,000, covered just six months of sales
in Japan. Cummins said BioVet now has plans to significantly expand
distribution of interferon for animal use, and hopes to go public
based on its increased sales, both of which should boost future Amarillo
royalties.
“More importantly, the regulatory approval in Japan could lead
to similar authorization for animal treatment in other Asian nations,
opening the door for Amarillo to enter into additional licensing and/or
royalty agreements since it currently retains rights to its technology
outside Japan. (Note: Though the exact fiscal impact of this deal
wasn’t detailed at the meeting, it is estimated that revenues
from the BioVet royalty alone could cover more than 10 percent of
Amarillo’s annual operating budget.)
“Two subjects that weren’t addressed in the meeting itself
but that came up in private conversations afterward were Amarillo’s
possible move to another location outside Texas and the use of interferon
to treat livestock against a possible terrorist attack using foot
and mouth (FMD) or other animal diseases.
“Dr. Cummins said he’d had discussions with business,
educational and/or political officials in West Virginia, Michigan
and New Mexico about relocating the company, but that there had been
no firm offers of financial or other incentives as yet. He also said
there was a strong possibility that, should an out-of-state proposal
be received, matching offers might come in from the Amarillo (City)
Economic Development Commission or the State of Texas, either of which
could induce the company to stay put.
“In other words, Dr. Cummins is now in a very enviable position.
He has four states, several cities and at least one U.S. Senator (West
Virginia’s Jay Rockefeller) competing for Amarillo’s presence
– and he may be able to play them off against one another in
an effort to lock in highly favorable financial and tax incentives
for future company operations.
“With respect to the terrorist issue and possible FMD treatment,
Dr. Cummins said talks were still on-going with various government
agencies and livestock industry organizations. The goal is development
of a program to utilize interferon as a cost-effective preventative
measure rather than waiting until after an attack and having to destroy
any afflicted herds.”
So, Larry’s report left off where mine shall resume –
with a mention of terrorism and the obvious appreciation for Amarillo
as a pure biotech company.
Sure, it’s a biotech in a dusty, friendly, mid-sized town –
but now, suddenly, it’s the politicians who are dusting off
the welcome mats for AMAR, not the other way around. Educational giants
with big budgets (such as West Virginia’s Marshall University
and its $12 million grant for biotech development within that state)
now lie at AMAR’s feet. And big-name Senators like Rockefeller
are rolling out the red carpet. And don’t forget Hayashibara,
which never once pulled the rug out from under Amarillo, but faithfully
stayed the course – the very long-term course – and is
now beginning to realize benefits from that investment.
This brings me to Larry’s earlier reference to Amarillo’s
new royalties – actually its first-ever royalties – resulting
from the BioVet-Hayashibara relationship in Japan. As he reported,
the first check was for $40,000. That isn’t big – but
the relationship is. That’s why the checks are likely to get
much, much larger – and arrive quite often. That, in turn, is
why I’d like to expand on what was said.
The Hayashibara pact to provide AMAR’s interferon to BioVet
is a very new deal and applies only to Japan – which may be
famous for its Kobe beef, but not for having very many of the cattle
that produces it. (In other words – and each of them with a
Southern drawl – all I mean to say is, “When it comes
to cattle, Japan ain’t no Texas!”) Yet, despite the deal
being young, BioVet being small and the Japanese cattle population
being even smaller, the potential for revenue growth – in the
opinion of the Asian equity markets – is so large and so obvious
that BioVet is now worth taking public. The offering is good to go;
the prospectuses have been printed.
I have not seen one, but a colleague familiar with the offering says
BioVet’s first-year revenues are expected to come in between
$10 million and $12 million. (Which only makes sense. After all, if
the company couldn’t do that, there wouldn’t be much point
in taking it public, would there?!) Aside from the overwhelming “out-of-the-gate”
sales response to AMAR’s product in BioVet’s hands, the
reason the sales are expected to expand rapidly is because BioVet’s
market is expected to expand rapidly, too, growing to include numerous
nations besides Japan.
Bottom line here? BioVet is going public almost solely on the basis
of our patents – and the fact that Hayashibara is right in the
middle. We’re in bed with Hayashibara – and have been
for over two decades, drawing more than $16 million in investment.
That really says a lot – as will the size and frequency of future
royalties. You see, the first $40,000 was based on Amarillo’s
8 percent share of Hayashibara’s first $500,000 sale to BioVet.
But, if BioVet meets the analysts’ expectations of $10 million
to $12 million, then our 8 percent suddenly grows from $40,000 to
something more like $1 million!
Other earlier projections will come true, too. For example, Avian
influenza now has every major world health organization
worried all the way to the top – a truth that is 100 percent
verifiable by hundreds of published papers and journals around the
world, and now, even in books. Much of this information is easily
accessed at Amarillo’s website – www.amarbio.com.
(Similar information can also be found at the website of Emergency
Filtration Products, Inc. – www.emergencyfiltration.com
– because of the obvious applications for EMFP’s nano-mask
technology).
It’s easy to appreciate why interferon could be a key in preventing
the “bird flu’s” growth into a pandemic. Just look
at how interferon was originally discovered: As a result of a 1950’s
outbreak of influenza. In fact, it was even given its name because
it was found to “interfere” with one particular strain
of the flu virus. It’s a natural fit.
Likewise, agro-terrorism is as real today as when I said to buy the
stock more than a year ago, then again in the fall and again in January
when departing Bush Cabinet member Tommy Thompson made a farewell
statement almost daring fanatics to attack America’s food supply.
And my BUY recommendation, based on the terrorist aspect alone, remains
as real as the threat.
But the importance of this BUY recommendation and this particular
document is to remind you that there are dozens and dozens of ways
that Amarillo’s technologies could affect both human science
and animal science – and its own share price. That’s the
basis for my profound recent interest in this stock
– “recent” being defined as the point at which I
recognized the company as being a potential shaker and mover in a
world that is itself being shaken and moved by unprecedented
events.
This much potential, prestigious business and research partners,
$37 million willingly invested so far – and lots more en route,
principally in the form of research grants and university-funded studies.
You know … scientists looking for the next big thing. Why? Because
it makes great sense – at least to those in the know. What does
not make sense is how Wall Street has missed this tiny
gem.
Seriously, how can this company have a market cap of just $5.93 million?
I used to blame the anomaly on geography – but Japan has found
it. State governments from Michigan to New Mexico have found it. Senators
on the opposite coast have found it. Look at the half a million shares
that traded last month alone. Then try to tell me that someone else
hasn’t also found it – and is aggressively accumulating
shares.
Do I sound angry? Well, I’m not. I’m just another incredulous
investor who’s not afraid to wait to be right. How hard can
that be?
We’re talking of a potentially world-class biotech in the making
– that is actually being made, as we speak, on many fronts,
with many partners, a score of patents, more than 1,350 shareholders
and …
… A total current market capitalization of just $5.93 million?
$5.93 million is not a typo – but, yes, it is
unbelievable. This whole Good Company for the price of a good
O.C. beach house.
To me, there is a large disconnect. It was there when I recommended
the stock at 8 cents, and at 10 cents, and at 12 cents – and
today, at 35 cents, where AMAR still holds its official title: The
Stewart Report’s “Favorite Speculation.”
P.S. – I am The Stewart Report, and I own a quarter-million
shares – and have for over one year. – JDS.
FINAL QUOTES (BUT NO NOTES):
International Card Establishment, Inc.
Nasdaq/BB: ICRD -- $0.41 – Up $0.08 since the last HotLine
Strong BUY to $0.50
Emergency Filtration Products, Inc.
Nasdaq/BB: EMFP – $0.40 – Down $0.03 since the last HotLine
Good BUY at Current Levels
As always, thank you for listening – and for subscribing.
J. David Stewart
Analyst and Publisher, The Stewart Report
Note: David’s HotLines are also available
24/7 by dialing (949) 583-6057, and
entering your subscriber-protected, 2-digit Pass Code at the prompt.
Information contained herein has been obtained from sources believed
to be reliable, but there is no guarantee as to completeness or accuracy.
Any opinions expressed herein are statements of our judgment on this
date and are subject to change without notice. Acting as an investor,
and also as a consultant to the Company, David Stewart purchased 250,000
shares of Amarillo Biosciences, restricted under Rule 144. J. David
Stewart currently owns 100,000 shares of ICRD common stock. Affiliates
of The Stewart Report may also have additional long or short positions
in these and other securities discussed herein, including warrants and/or
options, and may buy or sell same at their own discretion. This report
contains or may contain forward-looking statements within the meaning
of the "safe-harbor" provisions of the U.S. Private Securities
Litigation Reform Act of 1995. This report is intended for informational
purposes only and does not have regard for or take into consideration
the reader's investment objective, financial situation or suitability
for this security. Consult with your financial advisor and perform your
own due diligence. Copyright © The Stewart Report, 2005.