Company Overview
| Company Name |
DURATA THERAPEUTICS, INC. |
| Company Address |
200 SOUTH WACKER DRIVE SUITE 2550 CHICAGO, IL 60606 |
| Company Phone |
312-219-7000 |
| Company Website |
www.duratatherapeutics.com |
| CEO |
Paul R. Edick |
| Employees (as of 6/30/2012) |
22 |
| State of Inc |
DE |
| Fiscal Year End |
12/31 |
| Status |
Priced (7/19/2012) |
| Proposed Symbol |
DRTX |
| Exchange |
Nasdaq National Market |
| Share Price |
$9.00 |
| Shares Offered |
7,500,000 |
| Offer Amount |
$67,500,000.00 |
| Total Expenses |
$2,150,000.00 |
| Shares Over Alloted |
0 |
| Shareholder Shares Offered |
-- |
| Shares Outstanding |
17,240,363 |
| Lockup Period (days) |
180 |
| Lockup Expiration |
1/15/2013 |
| Quiet Period Expiration |
8/28/2012 |
| CIK |
0001544116 |
We estimate that the net proceeds from our issuance and sale of 7,500,000
shares of our common stock in this offering will be approximately $62.3
million, after deducting underwriting discounts and commissions and estimated
offering expenses payable by us. If the underwriters exercise their option to
purchase additional shares in full, we estimate that the net proceeds from this
offering will be approximately $71.8 million.
As of March 31, 2012, we had cash and cash equivalents of approximately $25.3
million. We currently estimate that we will use the net proceeds from this
offering, together with our cash and cash equivalents, as follows:
• approximately $13 million to complete the clinical development of and
seek marketing approval in the United States and the European Union for
dalbavancin for the treatment of patients with abSSSI;
• approximately $20 million to fund commercial activities for dalbavancin
in the United States and Western Europe, if it is approved for the
treatment of patients with abSSSI;
• approximately $15 million to fund the scale up of the manufacturing of
dalbavancin in preparation for commercial launch;
• approximately $10 million to pursue the development of dalbavancin in
additional indications; and
• the remainder for working capital and other general corporate purposes,
which may include the in-licensing or acquisition of other products or
technologies.
This expected use of the net proceeds from this offering and our existing cash
and cash equivalents represents our intentions based upon our current plans and
business conditions. The amounts and timing of our actual expenditures may vary
significantly depending on numerous factors, including the progress of our
development and commercialization efforts, the status of and results from
clinical trials, as well as any collaborations that we may enter into with
third parties for our product candidates, and any unforeseen cash needs. As a
result, our management will retain broad discretion over the allocation of the
net proceeds from this offering. We have no current understandings, agreements
or commitments for any material acquisitions or licenses of any products,
businesses or technologies.
Based on our planned use of the net proceeds from this offering and our
existing cash and cash equivalents, we estimate that such funds will be
sufficient to enable us to complete the clinical development of, to seek
marketing approval in the United States and the European Union for, and, if
approved for the treatment of patients with abSSSI, to commercially launch
dalbavancin in the United States and Western Europe. We have based this
estimate on assumptions that may prove to be wrong, and we could use our
available capital resources sooner than we currently expect. This estimate
assumes, among other things, that, at our sole discretion pursuant to the terms
of our agreement with Pfizer, we elect to defer for a period of up to five
years payment of the $25 million milestone that we will become obligated to pay
upon the first commercial sale of dalbavancin by delivering to Pfizer a
promissory note for such amount. Interest on the outstanding principal amount
of the promissory note will accrue at a rate of 10% per annum, compounded
annually.
Pending our use of the net proceeds from this offering, we intend to invest
the net proceeds in a variety of capital preservation investments, including
short-term, investment-grade, interest-bearing instruments and U.S. government
securities.
The biotechnology and pharmaceutical industries are characterized by rapidly
advancing technologies, intense competition and a strong emphasis on
proprietary products. While we believe that our clinical experience and
scientific knowledge provide us with competitive advantages, we face potential
competition from many different sources, including major pharmaceutical,
specialty pharmaceutical and biotechnology companies, academic institutions and
governmental agencies and public and private research institutions. Any product
candidates that we successfully develop and commercialize will compete with
existing therapies and new therapies that may become available in the future.
Many of our competitors have significantly greater financial resources and
expertise in research and development, manufacturing, preclinical testing,
conducting clinical trials, obtaining regulatory approvals and marketing
approved products than we do. Mergers and acquisitions in the pharmaceutical,
biotechnology and diagnostic industries may result in even more resources being
concentrated among a smaller number of our competitors. These competitors also
compete with us in recruiting and retaining qualified scientific and management
personnel and establishing clinical trial sites and patient registration for
clinical trials, as well as in acquiring technologies complementary to, or
necessary for, our programs. Smaller or early stage companies may also prove to
be significant competitors, particularly through collaborative arrangements
with large and established companies.
The key competitive factors affecting the success of dalbavancin, if approved,
are likely to be its efficacy, safety, convenience, price, use in out-patient
settings, the level of generic competition and the availability of
reimbursement from government and other third party payors.
Our commercial opportunity could be reduced or eliminated if our competitors
develop and commercialize products that are safer, more effective, have fewer
or less severe side effects, are more convenient or are less expensive than any
products that we may develop. Our competitors also may obtain FDA or other
regulatory approval for their products more rapidly than we may obtain approval
for ours. In addition, our ability to compete may be affected because in many
cases insurers or other third party payors seek to encourage the use of generic
products. Our industry is highly competitive and is currently dominated by
generic vancomycin, which generated sales of approximately $189 million in the
United States in 2011 and represented a majority of courses prescribed.
Additional products are expected to become available on a generic basis over
the coming years. If dalbavancin is approved, we expect that it will be priced
at a significant premium over competitive generic products.
Our potential competitors include large pharmaceutical and biotechnology
companies, and specialty pharmaceutical and generic drug companies, including
Pfizer, which markets Zyvox (linezolid) and Tygacil (tigecycline), Cubist
Pharmaceuticals, Inc., which markets Cubicin (daptomycin), Theravance, Inc.,
which markets Vibativ (telavancin), Forest Laboratories, Inc., which markets
Teflaro (ceftaroline), Sanofi-Aventis Ltd., which markets Targocid
(teicoplanin), and various producers of generic vancomycin. Further, we expect
that product candidates currently in late stage development, or that could
enter late stage clinical development in the near future, may represent
significant competition if approved. These include oritavancin (under
development by The Medicines Company for administration in a single dose with a
three-hour infusion time), tedizolid phosphate (under development by Trius
Therapeutics, Inc.), fusidic acid (under development by Cempra, Inc.),
delafloxin (under development by Rib-X Pharmaceuticals, Inc.), PTK 0796 (under
development by Paratek Pharmaceuticals, Inc.), BC-3781 (under development by
Nabriva Therapeutics AG), TP-434 (under development by Tetraphase
Pharmaceuticals, Inc.) and JNJ-Q2 (under development by Furiex Pharmaceuticals,
Inc.). Many of these companies may have significantly greater resources than we
have. If approved, we believe that dalbavancin’s features, including its
convenient dosing, compliance and efficacy with respect to MRSA, will
differentiate it from existing products currently marketed for the treatment
of abSSSI.
Company Description
We are a pharmaceutical company focused on the development and
commercialization of novel therapeutics for patients with infectious diseases
and acute illnesses. We are currently enrolling and dosing patients in two
global Phase 3 clinical trials with our lead product candidate, dalbavancin,
for the treatment of patients with acute bacterial skin and skin structure
infections, or abSSSI. Dalbavancin is an intravenous antibiotic product
candidate designed for once-weekly dosing, which we believe will facilitate the
treatment of patients with abSSSI in both the in-patient and out-patient
settings by reducing the length of a patient’s hospital stay or avoiding
hospital admission altogether and, ultimately, lowering the overall cost of
care for these patients. We are conducting each of these Phase 3 clinical
trials pursuant to special protocol agreements, or SPAs, with the U.S. Food and
Drug Administration, or FDA, based on draft guidance issued by the FDA in 2010
for the development of drugs to treat abSSSI. We also designed these trials
based on scientific advice that we received from the European Medicines Agency,
or EMA, in December 2010 to meet the regulatory filing requirements in the
European Union. We expect to complete these Phase 3 clinical trials and have
initial, top-line data available in the beginning of 2013. If our ongoing Phase
3 clinical trials are successful, we plan to submit a New Drug Application, or
NDA, to the FDA in the first half of 2013 and a marketing authorization
application, or MAA, to the EMA in the second half of 2013. If approved, we
intend to directly commercialize dalbavancin in the United States and Western
Europe with a targeted hospital sales force and to utilize a variety of types
of collaboration arrangements for commercialization in other markets.
We believe that dalbavancin offers a number of potential advantages compared to
currently available treatments for abSSSI, including a strong safety and
tolerability profile, broad coverage and activity against Gram-positive
bacteria, including resistant bacterial strains, suitability in a wide range of
patients due to limited drug-drug interaction or need for therapeutic drug
monitoring, and simpler administration that facilitates use in multiple
settings. In addition, dalbavancin’s pharmacokinetic profile and its relatively
long half-life compared to many currently available treatments result in
continuous bactericidal, or bacteria killing, activity over a prolonged period
of time following treatment. We believe that these potential advantages may
provide a more rapid and effective cure for patients with abSSSI, greater
patient compliance, improved safety outcomes and, even with branded pricing at
a premium to generic products, lower overall cost of care.
We own worldwide commercial rights to dalbavancin. Our worldwide rights are
royalty free, other than in Japan, where we are obligated to pay royalties on
net sales of dalbavancin. We will also owe a single milestone payment following
the first commercial sale of dalbavancin in the United States or one of five
major European markets, which we have the right to defer for up to five years.
Our dalbavancin rights include four U.S. patents covering dalbavancin’s use and
formulation. Each of these patents is scheduled to expire in 2023, and any one,
but not all, of these U.S. patents may be eligible for patent term extension.
If dalbavancin is approved by the EMA, we expect that dalbavancin will qualify
for eight years of data exclusivity and an additional two years of marketing
exclusivity in the European Union. In addition to abSSSI, we are pursuing
development of dalbavancin for additional indications, including osteomyelitis,
diabetic foot infection and pneumonia. We intend to enhance our product
pipeline through strategically in-licensing or acquiring clinical stage product
candidates or approved products for the hospital and acute care markets.
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We were incorporated under the laws of the State of Delaware on November 4,
2009 under the name Durata Therapeutics, Inc. Our principal executive offices
are located at 89 Headquarters Plaza North, 14 th Floor, Morristown, New Jersey
07960, and our telephone number is (973) 993-4865. Our website address is
www.duratatherapeutics.com.