DARA Reports First Quarter 2013 Financial Results and Operational Highlights
DARA Management to Host Conference Call and Webcast on Thursday, May
16, 2013 at 9:00 a.m. ET to Provide a Corporate Business Review and
RALEIGH, NC -- (Marketwired) -- 05/15/13 -- DARA BioSciences, Inc.
(NASDAQ: DARA), a specialty pharmaceutical company focused on
oncology and oncology supportive care products, announced today its
financial results for the first quarter ended March 31, 2013. The
Company also summarized the first quarter 2013 operational
highlights, its recent developments, and provided a commercial and
development pipeline review. DARA management will host a conference
call and webcast on Thursday, May 16 at 9:00 a.m. ET.
For the first quarter ended March 31, 2013, DARA reported a net loss
attributable to controlling interest of ($2,522,588), or ($0.11) per
share as compared to a net loss attributable to controlling interest
of ($1,983,876), or ($0.29) per share for the first quarter ended
March 31, 2012. The increase in loss was primarily a result of the
costs incurred in the establishment of a sales and marketing,
distribution and regulatory infrastructure to support the promotion
of the Company's oncology and oncology supportive care products
offset by a decrease in general and administrative expenses primarily
as a result of a reduction in audit and tax fees as well as the
absence of merger related costs in the first quarter of 2013. As of
March 31, 2013, cash and cash equivalents totaled $7,299,984.
DARA believes that its currently available funds, together with
projected sales of SoltamoxÂ®, GelclairÂ® and BionectÂ® in 2013 will
enable the Company to fund its planned operations and to meet its
obligations through December 31, 2013.
First Quarter 2013 Operational Highlights and Recent Developments
-- Strengthened its management team and board of directors by adding
substantial financial, commercial and business development expertise
with the appointment of David L. Tousley, Chief Financial Officer and
Paul J. Richardson, Independent Board Director;
-- Launched CAPTURE (Compliance and Preference for Tamoxifen Registry), a
breast cancer patient survey being performed at leading breast cancer
centers around the country 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;
-- Entered an agreement with Prime Therapeutics Specialty Pharmacy LLC for
distribution of its two lead proprietary products, Soltamox and
-- Launched the Company's third product, Gelclair (oral bioadhesive gel)
for the treatment of oral mucositis in April 2013; and
-- Implemented new commercial strategies to support Soltamox, Gelclair and
Bionect product launches.
"It has been just over a year since we merged DARA and Oncogenerix
and embarked on our new strategy with a commercial focus in oncology
and oncology supportive care. Overall, I am pleased with our progress
as we continue to execute on our business plan, but certainly
recognize that there is much more to do to realize the potential of
our assets and to fulfill our vision, which is to become a leading
player in the oncology supportive care area," stated David J. Drutz,
MD, chief executive officer and chief medical officer.
Drutz continued, "The past year has been one of transition and
integration of the new team in implementing our new strategy,
building a commercial infrastructure and launching three FDA-approved
products: Bionect, Soltamox and Gelclair. Our first quarter sales
results for Soltamox were disappointing, but we believe we understand
why we didn't achieve better results and have taken immediate action
in making the necessary adjustments to ensure we achieve the
expectations we have for this product. Importantly, the adjustments
we are making to our Soltamox sales and marketing plan have the
potential to positively impact the performance of our other
supportive care programs. In fact, early signs indicate good initial
uptake for Gelclair which was launched in late April. We believe
there is a significant market opportunity for each of our three
products as well as longer-term growth opportunities to in-license
additional supportive care products."
"I truly believe we have positioned DARA uniquely, have assembled a
strong team at the Company and have the opportunity to bring to
market important supportive care therapies for cancer patients, and
in turn, build significant value for our shareholders," concluded
Commercial Business Update
SoltamoxÂ®, tamoxifen citrate oral solution for the treatment of
DARA has exclusive commercial rights to Soltamox in the U.S., and
launched the drug formally in December 2012, coinciding with the 35th
Annual San Antonio Breast Cancer Symposium. Soltamox is the only
liquid form of tamoxifen available in the U.S. and may help those
breast cancer patients, and those at high risk for breast cancer, who
prefer liquid medication to adhere to their therapy.
In April 2013, DARA launched CAPTURE (Compliance and Preference for
Tamoxifen Registry), a breast cancer patient survey. The survey is
being 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,
By collecting data on over 600 tamoxifen patients, CAPTURE is
intended to enable health care providers to better understand the
complexities of patent adherence, and how patient preference or need
for a liquid form of tamoxifen may improve long term compliance. The
Company expects to publish the CAPTURE data, present it at scientific
meetings, and share the results with its key customers in order to
help educate healthcare professionals nationwide.
The Company has recently implemented several new sales and marketing
strategies and programs to yield the improved sales performance it
expects to see from Soltamox.
GelclairÂ®, an oral mucosa coating agent for the treatment of oral
In late April 2013, DARA launched Gelclair to the U.S. market where
it has exclusive U.S. commercial rights. 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 and a continuing preference for Gelclair over
other commercially available products used to treat oral mucositis.
DARA has commenced 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.
BionectÂ®, 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 Asset Update
KRN5500, for the treatment of painful chronic chemotherapy induced
peripheral neuropathy (CCIPN)
KRN5500 is a novel, non-narcotic/non-opioid intravenous Phase 2
product candidate for the treatment of painful CCIPN. As previously
reported, the U.S. Food and Drug Administration (FDA) has designated
KRN5500 a Fast Track drug, based on its potential usefulness in
treating a serious medical condition and in fulfilling an unmet
In November 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 its submission.
Additionally, DARA is pursuing partnering opportunities for KRN5500.
The Company is currently in active discussions with potential
partners to fund the further development of this asset. This will
allow the Company to focus its efforts and expertise and execute on
its commercial oncology and oncology supportive care strategy.
Conference Call and Webcast
DARA BioSciences will host a conference call and audio webcast
tomorrow, Thursday, May 16, 2013 at 9:00 a.m. ET to provide a
corporate business update and review financial results. Interested
participants and investors may access this conference call by dialing
877-407-9128 (U.S./Canada) or 201-493-6752 (international).
An audio webcast can also be accessed via the Investors section of
the DARA BioSciences corporate web site at http://www.darabio.com,
and will be archived for 30 days. Web participants are encouraged to
go to the web site 15 minutes prior to the start of the call to
register, download and install any necessary software.
A replay of the conference call will be available until May 30, 2013.
To access the replay, interested parties may dial 877-660-6853
(U.S./Canada) or 201-612-7415 (International); Conference ID: 414896.
A summary of key financial highlights for the three months ended
March 31, 2013 and 2012 is as follows ($ in thousands):
As of and for the As of and for the
three months ended three months ended
March 31, 2013 March 31, 2012
Net revenues $ 21.2 $ -
Gross Margin 3.7 -
Operating expenses 2,731.1 2,047.3
Net loss attributable to
controlling interest (2,522.6) (1,983.9)
Cash and cash equivalents 7,300.0 6,496.5
Current assets 7,911.0 7,044.8
Current liabilities 1,326.7 2,038.9
Working capital 6,584.3 5,005.9
About DARA BioSciences, Inc.
DARA is a specialty pharmaceutical company focused on the development
and commercialization of oncology treatment and supportive care
DARA increased its focus in oncology through its January 2012
acquisition of Oncogenerix, Inc., which holds the exclusive U.S.
marketing rights to SoltamoxÂ®, 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 prefer or cannot tolerate existing solid tablet
formulations of this drug. DARA has exclusive U.S. rights to Soltamox
through a license from Rosemont Pharmaceuticals, Ltd.
In June 2012, DARA launched its first product, BionectÂ®, 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. Soltamox was
launched formally as DARA's second commercial product in December
2012, coincident in timing with the 35th Annual San Antonio Breast
Cancer Symposium. In late April, 2013, DARA launched its third
product, GelclairÂ®, an FDA-cleared product for the treatment of oral
mucositis for which DARA also has exclusive U.S. commercial rights
through a license from Helsinn Group in Switzerland.
DARA is also developing a cancer-support therapeutic compound,
KRN5500, for the treatment of 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 Orphan Drug Application to the FDA for the use of this
drug in painful CCIPN.
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. Important factors that
could cause actual results to differ materially from the expectations
described in these forward-looking statements are set forth under the
caption "Risk Factors" in DARA's most recent Annual Report on Form
10-K, filed with the SEC on March 28, 2013. Those factors include
risks and uncertainties relating to DARA's ability to timely
commercialize and generate revenues or profits from BionectÂ®,
SoltamoxÂ®, GelclairÂ® 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.
Head of Investor Relations
Press spacebar to pause and continue. Press esc to stop.