We estimate that our net proceeds from this offering will be approximately
$55.8 million, assuming a public offering price of $9.50 per share, which is
the midpoint of the price range set forth on the cover page of this
prospectus, after deducting estimated underwriting discounts and commissions
and estimated offering expenses payable by us. If the underwriters exercise
their over-allotment option in full, we estimate that our net proceeds from
this offering will be approximately $64.4 million. Each $1.00 increase or
decrease in the assumed public offering price of $9.50 per share, which is the
midpoint of the price range set forth on the cover page of this prospectus,
would result in an approximately $6.0 million increase or decrease in our net
proceeds from this offering, assuming that the number of shares offered by
us, as set forth on the cover page of this prospectus, remains the same, and
after deducting the estimated underwriting discounts and commissions and
estimated offering expenses payable by us. Each increase or decrease of one
million shares in the number of shares to be offered by us would increase or
decrease our net proceeds from this offering by approximately $8.8 million,
assuming that the public offering price is $9.50 per share, the midpoint of
the price range set forth on the cover page of this prospectus and after
deducting the estimated underwriting discounts and commissions and estimated
offering expenses payable by us.
We expect to use the net proceeds of this offering to fund the clinical
development of our most advanced product candidates and for other general
corporate purposes.
Our management will have broad discretion over the uses of the net proceeds
from this offering. Pending application of the net proceeds, we intend to
invest the net proceeds in short-term, investment-grade, interest-bearing
securities.
Competition for BA058
The development and commercialization of new products to treat osteoporosis
and women's health is highly competitive, and there will be considerable
competition from major pharmaceutical, biotechnology and specialty
pharmaceutical companies. Many of our competitors have substantially more
resources than we do, including both financial and technical. In addition,
many of these companies have longer operating histories and more experience
than us in preclinical and clinical development, manufacturing, regulatory
and global commercialization.
Potential competitors with BA058 include, but are not limited to, Amgen, UCB,
Merck & Co., Novartis, Lilly, Asahi Kasei and Zosano. Lilly launched Forteo in
December 2002 as the first-to-market anabolic or bone-building agent for the
treatment of osteoporosis. In April 2012, UCB and Amgen started a Phase 3
clinical trial program for their sclerostin antibody for the treatment of
osteoporosis. Zosano and Asahi Kasei are also developing a transdermal form
of rhPTH(1-34) that would compete with BA058-TD. We have no products approved
for sale and therefore have no share of any therapeutic markets in which we
hope to introduce BA058.
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Competition for RAD1901
The development and commercialization of new products to treat women's health
is highly competitive, and there will be considerable competition from major
pharmaceutical, biotechnology and specialty pharmaceutical companies. Many of
our competitors have substantially more resources than we do, including both
financial and technical. In addition, many of these companies have longer
operating histories and more experience than us in preclinical and clinical
development, manufacturing, regulatory and global commercialization.
Our potential competitors in relation to RAD1901 include, but are not limited
to, Pfizer (NDA under review) and Depomed (Phase 3) who both have agents in
more advanced stages of development than RAD1901. We believe that RAD1901
will be able to compete with other agents for the treatment of hot flashes
because we expect it to have a similar efficacy and better safety profile
than estrogen products, as well as a better efficacy and safety profile than
non-estrogen products. We have no products approved for sale and therefore
have no share of any therapeutic markets in which we hope to introduce
RAD1901.
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Competition for RAD140
The development and commercialization of new products to treat women's health
is highly competitive, and there will be considerable competition from major
pharmaceutical, biotechnology and specialty pharmaceutical companies. Many of
our competitors have substantially more resources than we do, including both
financial and technical. In addition, many of these companies have longer
operating histories and more experience than us in preclinical and clinical
development, manufacturing, regulatory and global commercialization.
Potential competitors to Radius in relation to RAD140 include, but are not
limited to, GTx (Phase 3) and Ligand (Phase 1/2) who both have agents in more
advanced stages of development than RAD140. We believe that RAD140 will be
able to compete with other SARM agents because we expect it to have high
potency to increase muscle and bone with a strong safety profile. We have no
products approved for sale and therefore have no share of any therapeutic
markets in which we hope to introduce RAD140.
bone
building hormone. We are developing BA058 as a treatment for osteoporosis in
both injection (with BA058-SC, a subcutaneous injection currently in a Phase 3
clinical study) and transdermal (with BA058-TD, a short wear-time, transdermal
patch currently in a Phase 2 clinical study) methods of administration.
Osteoporosis is a disease characterized by low bone mass and structural
deterioration of bone tissue, which can lead to an increase in fractures. We
believe that BA058 stimulates the rapid formation of new, high-quality bone in
patients suffering from osteoporosis and may restore bone mineral density, or
BMD, in these patients into the normal reference range.
In August 2009, we announced positive Phase 2 data which showed that BA058-SC
produced faster and greater BMD increases at the spine and the hip with
substantially less hypercalcemia than Forteo, the only approved anabolic agent
for the treatment of osteoporosis in the United States. Specifically, our
study demonstrated that total analyzable hip BMD showed a more than five-fold
benefit of BA058 at a dose of 80 µg over Forteo after six months, and BA058
at a dose of 80 µg increased mean lumbar spine BMD by 6.7% at six months,
compared to 5.5% with Forteo, and by 12.9% at 12 months, compared to 8.6% with
Forteo. In April 2011, we began dosing patients in a pivotal, multinational
Phase 3 study designed to show that BA058-SC prevents new vertebral fracture
compared to placebo. We expect to report top-line 18-month fracture data from
this Phase 3 study in the fourth quarter of 2014. We believe that BA058 has
the following potential advantages over the current standard of care:
. greater efficacy;
. faster benefit for building bone;
. shorter treatment duration;
. less hypercalcemia;
. no additional safety risks; and
. no refrigeration required in use.
We are also developing BA058-TD, a short wear time, transdermal form of BA058
that is delivered using a patented microneedle patch technology from 3M Drug
Delivery Systems, or 3M. We commenced a Phase 2 clinical study of BA058-TD in
the third quarter of 2012, and expect top-line data from this study to be
available in the third quarter of 2013. We believe BA058-TD may eliminate the
need for daily injections, lead to better treatment compliance for patients
and expand the existing market. We reported the following top-line results
from a Phase 1b study in December 2011:
. rapid release of BA058 from the microneedle patch;
. peak transdermal drug levels consistent with BA058-SC;
. faster time to peak concentration, and faster elimination in plasma,
compared to BA058-SC;
. increase in the bone-formation marker P1NP in serum after seven days of
exposure, consistent with bone-building activity; and
. identification of optimal wear time of five minutes or less, and effective
sites of application.
We commenced a Phase 2 clinical study of BA058-TD during the third quarter of
2012, and expect top-line data from this study to be available in the third
quarter of 2013.
The NOF has estimated that 10 million people in the United States, comprising
eight million women and two million men, are already diagnosed with
osteoporosis, and another 34 million have low bone mass placing them at
increased risk for osteoporosis. In addition, the NOF has estimated that
osteoporosis was responsible for more than two million fractures in the United
States in 2005 resulting in an estimated $19 billion in costs. The NOF expects
that the number of fractures due to osteoporosis will rise to three million
by 2025.
There are two main types of osteoporosis drugs currently available in the
United States, anti-resorptive agents and anabolic agents. Anti-resorptive
agents act to prevent further bone loss by inhibiting the breakdown of bone,
whereas anabolic agents stimulate bone formation to build new, high-quality
bone. We believe there is a large unmet need in the market for osteoporosis
treatment because existing therapies have shortcomings in efficacy,
tolerability and convenience. For example, the current standard of care,
biophosphonates, an anti-resorptive agent, has been associated with
infrequent but serious adverse events such as osteonecrosis of the jaw,
atrial fibrillation and anomalous fractures, especially of long bones,
resulting from "frozen bone." These atypical fractures have created
increasing concern with physicians and patients. Many physicians are seeking
alternatives to current anti-resorptive therapies, which we believe will
drive greater demand for bone anabolic agents in the future. We believe there
is a significant opportunity for a new anabolic agent, such as BA058, that
will increase BMD to a greater degree and at a faster rate than other
approved drugs for the treatment of osteoporosis with added advantages in
convenience and safety.
We are also developing RAD1901, a SERM, which we license from Eisai in 2006.
We previously completed an initial one month Phase 2a clinical study for the
treatment of vasomotor symptoms, commonly known as hot flashes, in women
entering menopause. Our third product candidate, RAD140, is in preclinical
development. RAD140, a SARM, is an orally-active androgen agonist on muscle
and bone and is a potential treatment for age-related muscle loss, frailty,
weight loss associated with cancer cachexia and osteoporosis.
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We were incorporated in Delaware on February 4, 2008 under the name MPM
Acquisition Corp. In May 2011, we entered into a reverse merger transaction,
or the Merger, with our predecessor, Radius Health, Inc., a Delaware
corporation formed on October 3, 2003, or the Former Operating Company.
Pursuant to the Merger, the Former Operating Company became a wholly-owned
subsidiary of ours.
Immediately following the Merger, we merged the Former Operating Company with
and into us, and we assumed the business of the Former Operating Company and
changed our name to "Radius Health, Inc."
Our executive offices are located at 201 Broadway, 6th Floor, Cambridge,
MA 02139. Our telephone number is (617) 551-4700. Our website:
www.radiuspharm.com.