TWST: We'd like to begin with a brief historical sketch of NexMed and a picture
of the things you're doing at the present time.Ms. Liu: NexMed has been in existence since the end of 1995. We are a drug
development company focusing on the development of a broad portfolio of
innovative topical products that incorporate FDA-approved drugs with our
proprietary NexACT technology. We have targeted our development programs on
indications that would make a lot of sense to be treated topically, in order to
minimize or even avoid completely undesirable systemic side-effect profiles.
The differentiating factor of NexMed is our proprietary NexACT technology, which
I would be happy to discuss further. NexACT technology is a series of patented
permeation enhancers that significantly improve the delivery of drugs through
various membranes such as the skin and the nails, and other parts of the body.
The platform technology is patented and can be incorporated with a wide-range of
drugs into dosage forms such as creams, patches, lotions.
Our lead products include topical treatments for male and female sexual
dysfunction and for onychomycosis, or commonly known as nail fungus, which we
licensed to Novartis in 2005. When you look at the characteristics of these
products, it makes a lot of sense that the treatments are delivered topically.
Right now, these diseases may be treated orally which may have systemic side
effects, via injection, or some other undesirable delivery method. It makes a
lot of sense to improve the delivery through a topical delivery.TWST: What stage are you at with each of these? Also, what is the market size
potential in each case?Ms. Liu: We have focused our development program on potentially multibillion-
dollar markets. Novartis licensed our onychomycosis product for their next-
generation Lamisil program. You may recall the Lamisil ads that feature
"Digger," the undesirable fungus that lives under your nail, in the nail bed.
Lamisil is an effective oral product but causes severe systemic side effects in
a small number of patients, so all patients taking oral Lamisil are required to
have liver function tests every three months. Lamisil generates over $1 billion
in annual sales for Novartis and its patent coverage expires this year. Right
now, they are conducting two Phase III trials in the US and Europe, and we
anticipate that this product may be in the marketplace as early as 2009.
For our topical treatment for erectile dysfunction, we completed our Phase III
testing a while ago, and have been busy preparing for filing the marketing
application in the US, Europe and Canada in the very near future. The product is
intended for those patients who cannot or prefer not to take the oral treatments
such as Viagra due to its side effects. Although very efficacious, the oral
treatments are not for everyone. Also on the market are less patient friendly
treatments such as injections or intra-urethal pellets. Although very
efficacious if applied properly, these products are limited in sales because of
the way they're applied. The approximately $2 billion worldwide ED treatment
market is dominated by three oral treatments.
In terms of our female sexual arousal disorder product, we are in early Phase II
development in the US. This is potentially, a very large and untapped market
that many industry experts project to be the size, if not larger than, the ED
market. We are in active discussions with potential co-development partners to
take this product forward.TWST: I understand that female dysfunction is something that hasn't been
addressed as much as the erectile problem for men.Ms. Liu: That's 100% correct. First of all, female sexual dysfunction is much
more complex in diagnosis as compared to erectile dysfunction. There are
basically four sub-categories of female sexual dysfunction: disorders associated
with libido, arousal, pain and orgasm. We are focusing our efforts specifically
on arousal, which we believe can be treated with a topical alprostadil.
There is no product approved for treating arousal. When you hear about some
female products that have been approved, they are hormonal products related to
improving the libido. Recently, P&G was trying to get approval for Intrinsa.
Unfortunately, the FDA denied it based on insufficient safety data, but the
product is now being approved and introduced in Europe.TWST: Looking ahead regarding each of your three products, what challenges could
arise for you over the next few years?Ms. Liu: Certainly for product development, you're always concerned about the
regulatory climate and whether the agencies will provide the necessary guidance
to help you develop your product development program, as well as approval
issues. We're also very concerned about clinical challenges. Very often, you
have drugs that look good in the early stages, but when you test it in a larger
patient population, the results aren't as promising as you first thought they
would be. So those are the two primary concerns that we will have. What is
always important for small companies like us is financial considerations in
terms of having sufficient cash to drive our product development program.TWST: What is your cash situation like and what is your burn rate like?Ms. Liu: Our cash position is quite good. We're currently operating at a monthly
burn of about $450,000 and, as of March 31, we have about $10.6 million in cash.
That gives us close to two years of cash in the bank, and that is not including
the anticipated milestone payments that we will be receiving from Novartis. Our
agreement with Novartis provides for $51 million in milestone payments. We've
already received $4 million, and we anticipate that we'll receive an additional
$5 million during the next six to nine months. The rest of the payments will
hopefully take place in the next two years when the product is approved, and
after that, we will receive a royalty from Novartis.TWST: Is there anything that you would like to add regarding your strategic
agenda for the next few years?Ms. Liu: We have a very compelling story. We have a very unique platform
technology, meaning multiple products can be developed from this platform. The
technology is an acute transdermal delivery. So if you're looking to develop
products that require fast and efficient penetration and a very large quantity
of drugs through the various membranes, this is a great technology.
During the next six to eight years, it's widely agreed that 150 billion drugs
are going to be coming off patent, so the opportunity for drug delivery
companies like NexMed is very significant. We would be able to develop new
innovative treatments based on drugs that have known safety and efficacy
profiles. Also, you hear about companies pursuing the 505(b)(2) regulatory
strategy, which, if successfully pursued, enables the company to significantly
reduce time and resources. This is something that we have effectively achieved.
Under our Novartis program, we developed and implemented a 505(b)(2) strategy
that enabled Novartis to take the product from Phase I directly into pivotal
Phase III clinical testing. So we're hoping to repeat our success story.
Strategically, in three to five years, there is potentially significant upside
potential for NexMed.TWST: What might be some year-by-year milestones for investors to watch?Ms. Liu: In two or three years, I would be looking for the progress on the ED
product which will be the regulatory filings and obviously approval in the US,
Canada and Europe. I would also be looking for related commercialization
partnerships, whether it were a global licensing arrangement and/or regional
partnerships.
For the agreement with Novartis, there is an additional $47 million of milestone
payments that are anticipated during the 2007 to 2009 time frame, followed by
royalties that potentially translate into somewhere between $25 and $50 million
annually for the company.
For our female sexual arousal product, look for NexMed to enter into some type
of co-development partnership.
We haven't even had a chance to talk about some of the other earlier stage
products that we have in our pipeline. We will turn our resources to them once
we have completed the regulatory filings for our ED product. TWST: Would you give us a few hints about those?Ms. Liu: They're all topical treatments that are intended for unmet medical
needs. One opportunity is a treatment for premature ejaculation. It makes a lot
of sense to consider a topical approach to treating the condition. There is
really no effective treatment on the market. J&J unsuccessfully tried to go for
an oral treatment.
Another interesting product that we are considering is a topical treatment for
Raynaud's disease. That is the numbness in the extremities such as the
fingertips and the toes. For a lot of patients, that may just be an
inconvenience, but you do have a significant number of patients where the
numbness becomes painful and debilitating. If the condition gets very serious,
they need to go to the hospital for injections. So, once again, a topical
treatment for a patient to self apply makes a lot of sense. Hopefully, this
gives you an idea of some of the areas that we're looking at and exploring.TWST: Would you tell us about the backgrounds and the expertise of several of
the key members of the management team, yourself included?Ms. Liu: I've been with the company since its inception. I'm one of its
Founders. My background is in finance and I served as the company's CFO for an
extended period of time. Last year, I was promoted to Executive Vice President
and Chief Operating Officer for the company. Being with the company from its
inception, I know this company very well and look forward to contributing to its
growth.
Our CFO is Mark Westgate. He has been in the pharmaceutical business for the
past 10 or 12 years. Prior to that, he was in public accounting, so he is well
versed in the pharmaceutical business. Our Chief Scientists are Dr. Pfister and
Mr. Frank. They've been with the company pretty much since its inception as
well. We also have a very seasoned development team that's familiar with our
NexACT technology and has been able to make some technical breakthroughs.
We also utilize the services of renowned consultants who work very closely with
us. Being a small company, we don't have all the expertise in-house, but we have
some consultants of long standing especially in the clinical and regulatory
areas. TWST: As Founder, former CFO and current COO, what occupies your own attention
most, day by day?Ms. Liu: It's definitely our regulatory filings for our ED product program.
Those filings are going to take place in the US, Europe and Canada. We are in
that last stretch, so we hope to be there very soon. I'm also very much involved
and active in our investor relations program. This calls for a lot of my
attention to communicate our story to the investor community.TWST: What is your investor base like right now?Ms. Liu: Our investor base is maybe 65% institutional holders. Our larger
shareholder is Southpoint Capital, and our second largest now is Fidelity.TWST: How many employees does the company have?Ms. Liu: We currently have 18, and we have six additional temporary employees.TWST: Would you have to add many people as the company grows? Ms. Liu: Our focus for the next year or two is on our earlier stage development
programs, and our current staff is sufficient for that. We have no immediate
plans to increase our burn rate or our headcount. In fact, our pledge to our
investors is that we will hold to our current burn rate.TWST: What would be the two or three best reasons for the long-term investor to
look very closely at NexMed?Ms. Liu: The antifungal program that we have with Novartis is a very compelling
story. If you look at all the clinical work we've done, our investors are very
confident and are betting that Novartis, the marketer of Lamisil, will be able
to take our product forward, get it approved and make it into a blockbuster
drug. Novartis is a phenomenal marketer. We couldn't have partnered better.
What's also going to be a very exciting play is the NexACT technology. We have a
technical validation from Novartis that the technology works. We're looking to
deliver additional success stories about our technology and products under
development to our investors.
There are very few drug delivery technologies out there that can claim to have
the scope of safety and efficacy databases that we have. The opportunity for
additional product development in a much shorter period of time, with less
investment, and yet having great new products coming out of the pipeline is an
extremely exciting opportunity for the company. That's where the upside
potential will be.TWST: How much of an issue has Sarbanes-Oxley been for you?Ms. Liu: Sarbanes-Oxley has been challenging for all small companies. Our
current net market cap is over $100 million, and we were among the first group
to meet the 404 requirement. Our CFO, Mark Westgate, did a fine job. We passed
the test, and we were 404-compliant. It was a very expensive exercise for small
companies like us. I certainly look forward to the SEC giving more reprieves to
smaller companies. It is very costly for us to run our business with all the
rules and regulations that are imposed upon us. At the end of the day, we're not
a large company like GE, where transactions are much more complicated.TWST: Is there anything that you would like to add, especially regarding
strategies and long-term objectives?Ms. Liu: We have a very exciting and compelling story. We have a unique drug
delivery system that has multi-product potential, and we are pursuing a reduced
risk regulatory strategy which is something that we have demonstrated through
our Novartis agreement that we can do, and we will be able to do again. The
company in the last 18 months has transformed itself. So I very much look
forward to being part of the team that will take the company to the next level.
In another 18 months from now, I anticipate we're going to be an even more
different company, and we are all optimistic that it's going to be for the
better.TWST: Would you tell us about this transformation that has occurred?Ms. Liu: One of the Founders and the former CEO of the company left at the end
of 2005. At that time, we were operating at over $1 million a month in burn
rate. We had 45 employees spread out in three different facilities, and had
three months of cash left in the bank. So the challenge was to keep the company
afloat, restructure it, refocus it, reposition it, significantly reduce its cash
burn, improve its cash position and also keep it focused. I think we've
accomplished all of our goals, and we're a better, stronger company today as a
result of it.TWST: Is there anything you would like to add?Ms. Liu: I certainly invite anyone who has additional questions to call us. We'd
be happy to share our story. We have an exciting story and we are very proud to
tell it to whoever is interested.TWST: Thank you. (MC)VIVIAN LIU
EVP & COO
NexMed, Inc.
89 Twin Rivers Drive
East Windsor, NJ 08520
(609) 371-8123
(609) 426-9116 FAX
www.nexmed.com
Drug Delivery >> CEO Interview >> June 18, 2007
Vivian Liu
Vivian Liu
VIVIAN LIU has been the Executive Vice President and Chief Operating Officer of
NexMed, Inc., since January 2006, and Secretary since 1995. She served as Vice
President of Corporate Affairs from September 1995 until December 2005, Acting
Chief Executive Officer from December 2005 until January 2006, Chief Financial
Officer from January 2004 until December 2005, Acting Chief Financial Officer
from 1999 to January 2004 and Treasurer from September 1995 through December
2005... More










