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DARA BioSciences Reports Financial Results for the Third Quarter 2012

  DARA BioSciences Reports Financial Results for the Third Quarter 2012

Business Wire

RALEIGH, N.C. -- November 14, 2012

DARA BioSciences, Inc. (NASDAQ: DARA), a specialty pharmaceutical company
focused on oncology and oncology supportive care products, and owner of
exclusive U.S. marketing rights to Soltamox^®, a novel oral liquid formulation
of tamoxifen citrate, announced today financial results for the third quarter
ended September 30, 2012 in its Quarterly Report on Form 10-Q.

For the three months endedSeptember 30, 2012,DARA reported a net loss
attributable to common stockholders of $1,983,372, or($0.16)per share as
compared to a net loss of$921,478, or($0.18)per share for the same period
in 2011. The increase in loss was primarily a result of the costs incurred in
establishment of a sales and marketing infrastructure to support the promotion
of the Company's oncology and oncology supportive care products as well as an
increase in general and administrative expenses. As ofSeptember 30, 2012,
cash and cash equivalents totaled $8,259,476 and marketable securities totaled
$788,574.

Third Quarter and Recent Corporate Highlights:

  *In October, DARA launchedSoltamox^®(tamoxifen citrate) oral liquid
    solution in the United States with initial shipments of product to
    wholesalers and certain specialty pharmacy providers. Soltamox is a new
    treatment option for breast cancer patients who are prescribed tamoxifen
    therapy. DARA has exclusive U.S. rights to Soltamox from Rosemont
    Pharmaceuticals, Ltd, UK. Prior to DARA's launch of Soltamox, tamoxifen
    was only available in the U.S. as a solid oral tablet.
  *In September, DARA completed a series of agreements with a number of
    specialty pharmacy providers, leading group purchasing organizations
    (GPOs), retail partners, reimbursement experts, and an industry-leading
    third-party logistics provider, providing DARA comprehensive commercial
    coverage across the national oncology market. As part of an integrated
    national network with annual sales of over $1 billion in cancer
    therapeutics, DARA significantly enhanced its commercial scale and
    capabilities. Its distribution network now consists of more than 45,000
    retail pharmacies, mail order pharmacies, and long-term care facilities.
    This network provides DARA with established reimbursement and logistics
    expertise, with more than 300 sales and marketing personnel uniquely
    focused on oncology and oncology support products, and further provides
    the company with additional partnering opportunities.
  *In September, DARA entered into an exclusive agreement with theHelsinn
    Groupof Switzerland for U.S. commercial rights to Gelclair^®. Gelclair is
    an FDA-cleared, bioadherent oral protective gel product indicated for the
    treatment of oral mucositis, a painful inflammation and ulceration of the
    surface of the mouth and throat, which can result from a variety of cancer
    treatments. DARA plans to launch Gelclair late in the first quarter of
    2013.

  *In September, DARA reported that investors from the Company's April 2012
    public offering had voluntarily elected to exercise warrants to purchase
    approximately 1.2 million shares of the Company's common stock at $1 per
    share whereby the Company realized net proceeds of approximately $1.2
    million.
  *In July and August, DARA added two new directors to its board of
    directors:

       *Stephen O. Jaeger – Mr. Jaeger has more than 35 years of experience
         across a range of industries, including tenure at companies in the
         healthcare sector. He has served as director on boards including
         Savient Pharmaceuticals, Arlington Tankers LTD, eBT International
         Inc., Clinical Communications Group (a medical education company) and
         Hougton Mifflin. Mr. Jaeger also formerly served as chief executive
         officer of eBT International Inc.; and chief financial officer of
         Clinical Communications Group, Houghton Mifflin and Applera (a life
         sciences and instrument company).
       *Timothy J. Heady - Mr. Heady retired in 2011 as CEO of
         UnitedHealthcare Pharmacy, a unit of UnitedHealthcare (UNH)
         representing more than $11 billion in annual prescription drug
         spending. In that role, he was responsible for all aspects of the
         business, including pharmaceutical rebate contracting, retail
         pharmacy network development, customer and member services,
         operations, and financial performance. UnitedHealthcare Pharmacy
         provides pharmacy benefits and management for employers, both
         commercial and government, representing more than 14 million
         individuals.

  *During the quarter, DARA completed work to improve the formulation of KRN
    5500 and took steps to manufacture clinical material for anticipated
    clinical trials. DARA has also been engaged during the quarter in
    partnering discussions to advance ongoing development of the drug.

DARA CEO, David J. Drutz, MD, stated, “We have had a number of important
achievements since the beginning of the third quarter, many of which represent
critical steps toward realizing our goal of becoming a leading oncology and
oncology supportive care company in the United States. I am confident we now
have an extraordinary team in place and that we are positioned to effectively
execute against our business plan and strategy."

A summary of key financial highlights for the three and nine months ended
September 30, 2012 is as follows ($thousands):

                                    As of and        As of and      As of and
                  As of and for     for the          for the        for the
                  the three month   three month      nine month     nine month
                 period ended     period ended   period       period
                  September 30,     September        ended          ended
                  2012              30, 2011         September      September
                                                     30, 2012       30, 2011
Sales & Marketing 534.2            -              942.5        -
Research &        357.8            562.2          1,219.8      1,953.1
Development
General &         1,233.8          708.0          3,909.6      2,299.9
Administrative
Total operating   2,125.8          1,270.2        6,071.9      4,253.0
expenses
Loss attributable
to controlling    (1,983.4)        (921.5)        (5,439.8)    (3,740.9)
interest
Cash and cash     8,259.5          1,179.2        8,259.5      1,179.2
equivalents
Current assets    9,395.2          1,462.9        9,395.2      1,462.9
Current           1,437.2          868.0          1,437.2      868.0
liabilities
Working capital   7,958.0          594.9          7,958.0      594.9

About DARA BioSciences, Inc.

DARA is a specialty pharmaceutical company focused on the development and
commercialization of oncology treatment and supportive care products. DARA has
comprehensive commercial coverage across the national oncology market through
a series of agreements with a number of specialty pharmacy providers, leading
group purchasing organizations (GPOs), retail partners, reimbursement experts,
and an industry-leading third-party logistics provider. As part of an
integrated national network with annual sales of over $1 billion in cancer
therapeutics, DARA has significant commercial scale and capabilities. Its
distribution network consists of more than 45,000 retail pharmacies, mail
order pharmacies, and long-term care facilities. This provides DARA with
established reimbursement and logistics expertise, as well as partnering
opportunities with more than 300 sales and marketing personnel uniquely
focused on oncology and oncology support products. This comprehensive network
of partners is rare if not unique among companies in the oncology supportive
care area and provides DARA a strong foundation for product introductions into
this underserved market.

DARA increased its focus in oncology through its January 2012 acquisition of
Oncogenerix, Inc., which holds the exclusive U.S. marketing rights to
Soltamox^®, a novel oral liquid formulation of tamoxifen citrate, which is
widely used in the treatment and prevention of breast cancer. Soltamox is the
only FDA-approved oral liquid version of tamoxifen citrate and fulfills a
vital clinical need for patients who cannot tolerate existing solid tablet
formulations of this drug. DARA launched Soltamox in October 2012 to coincide
with National Breast Cancer Awareness Month. DARA has exclusive U.S. rights to
Soltamox through a license from Rosemont Pharmaceuticals, Ltd. Additionally,
in June 2012, DARA launched its first product, Bionect^®, a topical treatment
for skin irritation and burns associated with radiation therapy. DARA has
rights to market Bionect in the US oncology/radiology markets under license
from Innocutis. In September 2012, DARA entered into an exclusive agreement
with the Helsinn Group of Switzerland for U.S. commercial rights to
Gelclair^®, an FDA-cleared product for the treatment of oral mucositis. DARA
plans to launch Gelclair in the first quarter of 2013.

Prior to acquiring Oncogenerix, DARA was focused on the development of a
cancer-support therapeutic compound, KRN5500, for the treatment of neuropathic
pain in patients with cancer. This product has successfully completed a Phase
2a clinical trial, and has been designated a Fast Track Drug by the United
States Food and Drug Administration. DARA is working with the National Cancer
Institute (NCI) to design an additional clinical trial under joint DARA-NCI
auspices while continuing to pursue partnering discussions.

In addition to its oncology products, DARA’s pipeline includes DB959, a novel,
non-TZD dual delta/gamma PPAR agonist for the treatment of type 2 diabetes and
dyslipidemia. DARA has completed Phase 1 testing of DB959 and is presently
pursuing opportunities to out-license this product.

For more information please visit our web site at www.darabio.com.

Safe Harbor Statement

All statements in this news release that are not historical are
forward-looking statements within the meaning of the Securities Exchange Act
of 1934, as amended. Such forward-looking statements are subject to factors
that could cause actual results to differ materially for DARA from those
projected. Those factors include risks and uncertainties relating to DARA's
ability to timely commercialize and generate revenues or profits from
Bionect^®, Soltamox®, Gelclair® or other products given that DARA only
recently hired its initial sales force and DARA's lack of history as a
revenue-generating company, FDA and other regulatory risks relating to DARA's
ability to market Bionect, Soltamox, Gelclair or other products in the U.S. or
elsewhere, DARA's ability to develop and bring new products to market as
anticipated, DARA's current cash position and its need to raise additional
capital in order to be able to continue to fund its operations, the current
regulatory environment in which DARA develops and sells its products, the
market acceptance of those products, dependence on partners, successful
performance under collaborative and other commercial agreements, competition,
the strength of DARA's intellectual property and the intellectual property of
others, the potential delisting of DARA's common stock from the NASDAQ Capital
Market, risks and uncertainties relating to DARA's ability to successfully
integrate Oncogenerix and other risk factors identified in the documents DARA
has filed, or will file, with the Securities and Exchange Commission ("SEC").
Copies of DARA's filings with the SEC may be obtained from the SEC Internet
site at http://www.sec.gov. DARA expressly disclaims any obligation or
undertaking to release publicly any updates or revisions to any
forward-looking statements contained herein to reflect any change in DARA's
expectations with regard thereto or any change in events, conditions, or
circumstances on which any such statements are based. DARA BioSciences and the
DARA logo are trademarks of DARA BioSciences, Inc.

Contact:

For DARA BioSciences, Inc.:
The Del Mar Consulting Group, Inc.
Robert B. Prag, President
858-794-9500
bprag@delmarconsulting.com
or
Alex Partners, LLC
Scott Wilfong, President
425-242-0891
scott@alexpartnersllc.com
 
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