DARA Reports Year-End 2012 Financial Results

DARA Reports Year-End 2012 Financial Results 
Company Provides a Commercial Portfolio and Development Pipeline
Business Update 
RALEIGH, NC  -- (Marketwire) -- 04/01/13 --   DARA BioSciences, Inc.
(NASDAQ: DARA), a specialty pharmaceutical company focused on
oncology and oncology supportive care products, announced today its
financial results for the year ended December 31, 2012 and provided a
commercial and development pipeline business update. 
For the year ended December 31, 2012, DARA reported a net loss
attributable to controlling interest of ($7,311,033), or ($0.60) per
share as compared to a net loss attributable to controlling interest
of ($6,170,588), or ($1.20) per share for the year ended December 31,
2011. The increase in loss was primarily a result of the costs
incurred in the establishment of a sales and marketing infrastructure
to support the promotion of the Company's oncology and oncology
supportive care products as well as a related increase in general and
administrative expenses as the Company transitioned from what had
been solely a research and development company. As of December 31,
2012, cash and cash equivalents and available for sale investments
totaled approximately $6,593,000. In addition, between December 31,
2012 and March 28, 2013, the Company received approximately
$2,516,000 in net proceeds from the issuance of convertible preferred
stock and approximately $1,221,000 in net proceeds from the exercise
of warrants. DARA believes that its currently available funds,
together with projected sales of Soltamox® and Gelclair® in 2013,
will enable the Company to fund its planned operations and to meet
its obligations through at least December 31, 2013.  
Fourth Quarter 2012 Operational Highlights and Recent Developments  


 
--  Strengthened its board of directors with the appointment of two highly
    experienced and respected industry experts; Tim Heady and Paul
    Richardson, both new directors
--  Regained compliance with NASDAQ's $1.00 minimum bid price rule
--  Raised approximately $2.5 million in net proceeds pursuant to a
    securities purchase agreement
--  Announced the U.S. launch of Soltamox® (tamoxifen citrate) oral
    solution, the first and only liquid version of tamoxifen citrate
--  Prepared for the launch of Gelcla
ir® for the treatment of oral mucositis

 
"2012 was a momentous year for DARA, specifically with the launch of
our first drug, Soltamox, in the oncology market for patients with
breast cancer," said David J. Drutz, M.D., DARA's chief executive
officer. "It is a time of great pride and excitement for the Company,
with Soltamox representing the first of what we expect will be many
oncology and oncology supportive care treatments resulting from our
combined development and acquisition strategy. With the launch of
Gelclair for patients with oral mucositis scheduled for this month
and the continued development of KRN5500 for painful chronic
chemotherapy induced peripheral neuropathy (CCIPN), DARA is moving
forward as a leader in the oncology and oncology supportive care
market and executing against our corporate plan." 
Commercial Business Update  
Soltamox ® , tamoxifen citrate oral solution for the treatment of
breast cancer
DARA has exclusive commercial rights to Soltamox in the U.S. Soltamox
is the only liquid form of tamoxifen available in the U.S. and may
help breast cancer patients, and those at high risk for breast
cancer, adhere to their therapy on a long term basis. To date,
Soltamox has moved from wholesaler inventory over 135 Soltamox
patient prescriptions filled by retail and specialty pharmacies
nationwide as well as through institutional and hospital accounts.
Recently completed market research, with over 100 oncology health
care professionals, indicates an increasing awareness of Soltamox.
Over one third of respondents, who were aware of Soltamox, indicated
that they either have prescribed or plan to prescribe the product.
These oncology professionals see Soltamox as a useful alternative for
patients who either have a swallowing difficulty or who simply prefer
a liquid formulation. 
DARA also announced today the launch of CAPTURE (Compliance and
Preference for Tamoxifen Registry), a breast cancer patient survey.
The survey will be performed at leading breast cancer centers around
the country, and is designed to gain insights into several important
aspects of breast cancer treatment, including patient adherence to
tamoxifen therapy, prevalence and severity of swallowing
difficulties, and patient preference for Soltamox (tamoxifen citrate)
oral solution vs. tamoxifen tablets. CAPTURE was developed in
conjunction with a Scientific Steering Committee, including two
highly recognized leaders in the fields of oncology and breast
cancer, Stefan Gluck, M.D., Ph.D., Sylvester Distinguished Professor,
Department of Medicine, Division of Hematology/Oncology, Sylvester
Comprehensive Cancer Center, University of Miami, FL; and Jivesh
Sharma, M.D., Presbyterian Hospital of Dallas, TX and CEO of NEXGEN
Oncology, Dallas. 
By collecting data on over 600 tamoxifen patients, CAPTURE is
intended to enable health care providers to better understand the
complexities of patent adherence, prevalence of swallowing
difficulties, and patient preference for a liquid form of tamoxifen.
We expect that the information collected via CAPTURE will be
published, in order to share results of the survey and help educate
healthcare professionals nationwide.  
"Soltamox has an important place in the oncology market," commented
David Benharris, DARA's vice president of sales, marketing and
business development. "Our recently completed market research,
conducted with over 100 oncology physicians and nurses, shows a need
for an oral liquid formulation in up to ten percent of patients on
tamoxifen who find it difficult to take pills or prefer liquid
formulations. As we continue our efforts to educate patients and
health care professionals regarding Soltamox, CAPTURE provides an
excellent opportunity to increase awareness as well as provide
valuable data for publication and education." Benharris continued,
"Additional programs to increase awareness are ongoing and include
direct-to-patient education provided as a supplement attached to
tamoxifen prescriptions, continuing sales and outreach campaigns to
health care professionals and patients by our specialty pharmacy
network, sampling of Soltamox to high volume prescribers of
tamoxifen, and a national tele-detailing program to targeted offices
which are the highest utilizers of tamoxifen therapy." 
Gelclair ® , an oral mucosa coating agent for the treatment of oral
mucositis
DARA is planning for the reintroduction of Gelclair to the U.S.
market in April of this year. DARA has exclusive U.S. commercial
rights to Gelclair. Internally conducted market research involving
over 100 oncology physicians and nurses indicated strong familiarity
with the Gelclair brand from its earlier presence in the U.S. market;
a continuing preference for Gelclair over other commercially
available products used to treat oral mucositis. DARA is currently
working to commence a direct-to-patient specialty single point of
contact model, the Gelclair Access Program, to provide product access
and affordability for patients together with ease of prescribing for
health care providers. 
Bionect ® , a topical low molecular weight hyaluronic acid for the
treatment of radiation skin injury 
DARA launched Bionect in the second quarter of 2012. Over 100
accounts have used this product for 
the treatment of
radiation-related skin damage and a national network of cancer
treatment centers is currently establishing Bionect as first-line
therapy for both inpatient and outpatient usage. 
Development Pipeline Update  
KRN5500, for the treatment of painful chronic chemotherapy induced
neuropathy (CCIPN)
DARA has strengthened its Phase 2 proprietary asset, KRN5500, a
novel, non-narcotic/non-opioid intravenous product for the treatment
of painful CCIPN. A new formulation of KRN5500 has been established
with the goals of providing ease of use, compliance with FDA
regulations, and additional patent protection. At the end of 2012, an
application to the FDA for an Orphan designation for painful CCIPN
was submitted for review. DARA is currently in communication with the
FDA regarding the submission for Orphan designation. Additionally,
the FDA has already designated KRN5500 a Fast Track drug, based on
its potential usefulness in treating a serious medical condition and
in fulfilling an unmet medical need. DARA is currently pursuing
partnering opportunities for the development and commercialization of
KRN5500. 
A summary of key financial highlights for the years ended December
31, 2012 and 2011 is as follows ($ in thousands): 


 
                                                                            
                                                                            
                                                                            
                                      As of and for the   As of and for the 
                                             year ended          year ended 
                                      December 31, 2012   December 31, 2011 
Net revenues                         $             53.6  $                - 
Gross Margin                                       29.8                   - 
Operating expenses                              9,666.9             6,761.9 
Net loss attributable to controlling                                        
 interest                                      (7,311.0)           (6,170.6)
Cash and cash equivalents                       6,496.5             1,179.2 
Current assets                                  7,044.8             1,462.9 
Current liabilities                             2,038.8               868.0 
Working capital                                 5,006.0               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. DARA also has exclusive U.S. commercial rights to
Gelclair®, an FDA-cleared product for the treatment of oral
mucositis, which DARA plans to launch in April, 2013. 
DARA is also developing a cancer-support therapeutic compound,
KRN5500, for the treatment of painful chronic chemotherapy-induced
peripheral neuropathy (CCIPN) in patients with cancer. This product
is an excellent fit with DARA's strategic oncology focus, has
successfully completed a Phase 2a clinical trial, and has been
designated a Fast Track Drug by the FDA. DARA has created an
improved, potentially commercializable formulation of this drug and
is in active partnering discussions regarding further clinical
development. DARA has also submitted an Application to the FDA for
the designation of KRN5500 as an Orphan Drug for use in painful
CCIPN.  
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 o
ther 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:
Jenene Thomas
Investor Relations + Corporate Communications Advisor
+1-908-938-1475
jthomas@darabio.com
 
 
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