TWST: What is Millenium Biologix?Mr. Pugh: Millenium Biologix is a unique orthobiologics company with a
focus on delivering solutions in the area of regenerative medicine for
skeletal tissues, principally cartilage, bone, and tendon. We're unique
because unlike most companies in our sector that talk about
orthobiologics as the combination of just two technologies ' that is,
combined biomaterial scaffolds and growth factor as implants ' we
achieve the key differentiating goal of our company, which is to provide
not only direct orthobiologic implants, but also a patient's own cells
and tissues grown outside the body in the form of autologous cell
therapy and tissue engineering solutions. In order to achieve this, we
have developed a third proprietary technology platform in bioengineering
to complement our synthetic bone scaffolds and growth factors, and this
combination allows us to provide an array of therapies that makes us
unique. We can enable cell therapy directly in the hospital with a very
exciting new product line that we are going to be launching in 2005. So
it's the combination of three technology platforms ' advanced
biomaterials for bone, growth factors plus the engineering expertise to
carry out ex vivo cell multiplication and tissue growth ' that provides
our strength in depth.TWST: Give us the background of what those areas of science look like as
far as markets today and how they're currently being addressed. What's
the differential that Millenium Biologix can bring to that market?Mr. Pugh: On the biomaterial scaffold side, which is the basic building
block, this is the piece that provides the physical replacement
necessary to either fix a trauma site or to replace diseased bone and
other associated skeletal tissues. That market is one that is still
dominated by the use of autograft. Alternatives in the form of bone
graft substitutes have been marginal in performance to date, and what we
bring as a breakthrough in that area is our Skelite_ technology. This is
a proprietary synthetic bone graft scaffold, in which we have uncovered
the role of trace elements that are found in normal bone that were
thought to be benign and have no effect. We have discovered that, in
fact, if you incorporate these elements in synthetic bone graft
scaffolds, you actually get a unique biological effect whereby the
implant is gradually and completely replaced over time. In the first
phase after implantation, Skelite promotes good healing; this is
followed by natural replacement, and this combination provides the ideal
outcomes the surgeon and the patient want. So that's the first thing
that we bring. That market internationally is around $200 million, but
the potential for that sector is probably $1.5 billion. Patients often
suffer chronic pain at the harvest site when they have the costly dual
surgery which is necessary for autograft harvesting. Because of this,
surgeons are looking for a replacement for autograft, the so-called gold
standard. So market potential is great. There is a lot of growth
potential in synthetic bone graft substitutes. But to be well accepted,
they need to have this unique biological characteristic of being
remodeled over time that matches the body's own normal bone turnover,
and that's what we've captured in our Skelite technology. In the area
of growth factors, that market is just opening up. There are some very
exciting numbers out of the independent analysts who are forecasting
market potentials that range from $2 billion to $3 billion. I think
that's being validated by the first two products in the market; the
first one is InFUSE, from Medtronic Sofamor Danek, and the second
product is OP-1 from Stryker. Already, in the case of InFUSE which has
only been on the market for around 18 months in the US and is not
significantly used in any other world markets, analysts' reports in the
second quarter of 2004 were showing sales of over $1 million a day of
this product. So the run rates we estimate at the moment for those two
products combined is probably somewhere in the region of $600 million to
$700 million a year, less than two years after their launch. These
growth factors open up the possibility to treat more difficult cases
and, again, seek to provide the ideal goal of long term, best outcomes
for patients, so they will not come back with recurring problems. That
market opportunity is just beginning to be realized, and it's opening up
the biological future for orthopedics. It's the one that has created
this whole new term, orthobiologics, which is deemed by many to be the
future for this sector. So that's the first two areas in which we
compete. The third area, which is that of cell therapy and regenerative
medicine, is truly just emerging. One of the things that we believe has
made it a slow-to-get-started business is that, first of all, it is
technologically quite challenging. Also, the industry has pursued a very
standard model in that it has put itself in the position of being the
source of the biological material. In other words, biopsies of
cartilage, for example, will be taken from a healthy site and sent to a
remote industry facility. In North America, the primary facility, and
maybe the only one on a commercial scale, is run by Genzyme Biosciences
in Boston. There are, similarly, a few companies in Europe; Verigen and
co.don, for example, trying to do similar things. But the logistics of
it ' the costs and risks of shipping these biological materials, often
across national borders and certainly over long distances ' is hugely
challenging. Because of that, this market, where there are a million
surgical interventions a year for cartilage repair alone, is
commercially still quite small, maybe only $100 million at the moment.
But clearly, if better solutions can be found, especially coinciding
with developments in early intervention and minimally invasive surgery
brought along by arthroscopy and so forth, the market is several billion
dollars, possibly even eclipsing ultimately the growth factor and the
bone graft scaffolds market. That's really where we feel we have an
exciting opportunity to actually own a market, rather than with the
first two products where we will compete very effectively.TWST: How strong financially is Millenium Biologix? Is it a question of
an accelerating burn rate?Mr. Pugh: Yes, but not an exponentially accelerating burn rate. We were
very fortunate from the start. When we founded the company, we
identified an early niche opportunity for our first technology, which
was our synthetic bone graft technology in the research market, and that
allowed us to both prove our capabilities to develop products and get
them on the market and get them accepted, and to partner successfully,
in this case with Becton Dickinson, to sell that product for us. So
we've been in the position of generating revenues from a complementary
source in that this was a technology we were developing for implant
purposes, which has helped to fund the development and the regulatory
approval and the partnering of our first clinical product. So we have a
history of generating revenues. So our financial position right now,
with the successful closing of a private round that was concurrent with
us going public recently, has given us adequate resources to deliver our
business objectives and forecast profitability in the medium term.TWST: Introduce us to your top-level management team, and provide us
with your assessment as you look at bench strengths and skill sets,
opportunities and timelines. Will you need to add or augment that team?Mr. Pugh: Our top-line team at the moment consists of Ian Malone, who is
our Chief Financial Officer. He was a very experienced international
banker before moving on and successfully helping finance companies
through IPOs and on to success. I still, to a large degree, take care of
the business and the marketing side in terms of the top-level strategy.
We have a product management group here in North America and also in
Europe because we have offices in Zrich as well as in North America.
Our science leader is the person I started the company with, Dr. Tim
Smith. His basic background is in biomaterials and bioengineering. Also,
further in the finance area, we have a very experienced senior
accountant in the capacity of Controller. In Zrich, we were very
fortunate, arising from an early collaboration with Sulzer Orthopedics,
in being able to hire two Chief Scientists, Dr. Rupert Hagg andDr. Roberto Tommasini, from Sulzer's cartilage program. They know the
cartilage tissue engineering field very well, and they form the nucleus
of our group that has been highly productive in Switzerland, which is
not only an R&D center, but also a business base for our expanding
commercial operations over there. So that's a quick snapshot. You asked
me the question about near-term hires. We've succeeded in hiring a
General Manager for Europe who begins on February 2. This very
experienced senior Belgian national speaks five languages and has done
the kind of thing that we are asking him to do several times
successfully before in Europe. Also, here in North America, we are
currently searching for a VP R&D, and a VP Global Marketing, and are
about to close on a Director of Business Development.TWST: What is the agenda at this point? What are the priorities for the
next 12 to 24 months? What would make that time frame a success from
your perspective?Mr. Pugh: We have the Skelite line of synthetic bone grafts now being
sold in North America. It is our goal by the end of 2005 to have
successfully launched our first growth factor product and the Skelite
products in Europe, to have successfully launched our first in the
family of Autologous Clinical Tissue Engineering Systems (ACTES_) in
both Europe and North America, and by the middle of 2006, by which time
we hope to have concluded successful clinical trials for our growth
factor in the US, to have launched our first growth factor products in
the United States. So there are 18 very busy months ahead, by which time
we will have three clinical product lines on the market, each of which
represents a family of products with multiple line extension
opportunities into the future.TWST: At this point, what role can mergers and acquisitions play as you
look at your opportunities to grow and to build? How suitable is
Millenium Biologix as a target for acquisition?Mr. Pugh: We look at M&A in two ways. One is, of course, we recognize
that as we become more and more successful, we become an acquisition
target. While we don't plan for that, if it comes along and is with the
right partner and it looks as if it is going to be a win-win scenario,
of course we would look at it. The other way that we look at M&A is
doing the acquiring ourselves. Now that we are a public company and have
access to capital markets that give us the potential to look at M&A
opportunities, I expect that we will become active in this regard. We
are increasingly being approached with complementary technologies and
business opportunities, so therefore M&A for us is a two-way street.TWST: To date, what has been the investor or funding history, and what
does the shareholder universe look like today? Is that base undergoing
any changes or transitions?Mr. Pugh: We are very focused on product development and timely delivery
of products to the market. Being in the device sector, time and cost to
market are significantly more favorable than the biopharma sector.
Additionally, we've generated early revenues, actually taking the
company all the way to our first FDA clinical product approval with no
external investors other than the money that my partner and I put in to
start the company, and a lot of sweat equity. Also, being here in
Canada, significant help has come from Canadian government programs,
groups like the National Research Council and, of course, Canada's
extremely favorable investment tax credit for R&D companies. However, in
2002, as we obtained US FDA approval for our first clinical product,
Skelite, we welcomed investment from Genesys Capital Partners, a VC
group in Toronto, Canada. Until we succeeded in closing the private
offering concurrent with the closing of the RTO a few weeks ago, they
were our only external investors. We funded early growth and development
internally to a very large degree. Now, as a public company we've
welcomed some high-quality institutional investors, not only from
Canada, but with international participation. What we're looking to do
in the early part of 2005 is becoming better known among the
international investment community. Our tradition has been, in whatever
we've done, to pursue quality. This is as important to maintain on the
investor front as it is in all of our products and other activities. I
think also what's very attractive about our story is that it is easy to
understand by the retail side. Most people, either themselves or their
close family and friends, have orthopedic problems, and everyone
understands the fundamental demographic driving this business; an aging
population and the rapid emergence of sports medicine. So I think the
company will be appealing both to quality institutional investors who
will be absolutely vital as we expand internationally, principally, with
a focus on the US and Europe, and also, a story that will attract the
interest and commitment probably of the retail sector. So I think it's
an exciting time ahead for us.TWST: What compels investors to review Millenium Biologix and include it
in their current portfolios and in their longer-term investment
strategies?Mr. Pugh: Bearing in mind our focus is orthopedics, I was really pleased
to read a recent interview by the President of the world's number one
orthopedics company, Zimmer, and in it, he refers to them needing an
acquisition in the cartilage space. What we're going to do in the area
of skeletal tissue engineering regenerative medicine is essentially make
redundant the use of many metal implants for knees, hips and shoulders
by early intervention to provide both cell and tissue solutions in the
hospital through an automated system that can be put into any center of
excellence hospital to do that kind of therapy. I think that's the most
important thing, and it is not science fiction. This is a product line
that we've already previewed at important international meetings. We
have a bone program, and tendon, ligament and disk programs behind this
as well. So this is a real platform capability to match the growth of
early intervention and biological solutions. So I think the really
compelling story for the investor is if they look around even to the
highest pinnacles of achievement of the orthopedic sector right now in
terms of the industry, and look at the needs that those corporations are
defining, that's exactly what we're bringing to the table through the
next 12 to 24 months.TWST: Are there any thoughts or issues you'd care to include that we
haven't touched on?Mr. Pugh: Our short-term goal is to have these three clinical product
lines representing our three technology platforms on the market within
12 to 18 months from now so that people can fully comprehend the power
of what we bring into play through partnerships. That's one thing we
haven't touched on. We have generated some excellent commercial and
academic partnerships on our way, and they're going to be key to our
future, but also, it's a future where increasingly we're going to be
branded in the marketplace. We are increasingly doing co-marketing.
That's why we've expanded our sales and marketing efforts, and we're
looking to grow that internationally. High-quality partnerships will
remain central to our strategy. But we intend to establish our own brand
in the marketplace that will increasingly make Millenium Biologix a name
that instantly brings differentiation and a smile to the faces of
orthopedic surgeons, their patients and our shareholders.TWST: Thank you. (DWA)SYDNEY M. PUGH
Chairman & CEO
Millenium Biologix Corporation
785 Midpark Drive
Kingston, Ontario K7M 7G3
Canada
(613) 389-6565
(613) 389-6625 - FAX
www.millenium-biologix.com
e-mail: investor@millenium-biologix.comCopyright 2005 The Wall Street Transcript Corporation
All Rights Reserved
Biotechnology >> CEO Interview >> January 10, 2005
SYDNEY PUGH
SYDNEY M. PUGH is Chairman, Chief Executive Officer and a Director of
Millenium Biologix Corporation. Mr. Pugh co-founded Millenium with Dr.
Timothy Smith in 1992. Prior to founding Millenium, he led several
startup companies and corporate expansions throughout Europe and North
America. During his extensive international career with Baxter
Healthcare, Bayer Corp... More










