DURECT Corporation Announces Earnings and Reports Strong Progress on Its Business

Download PDF:

CUPERTINO, Calif., Feb. 16 /PRNewswire/ — DURECT Corporation
(Nasdaq: DRRX) announced today financial results for the three months and year
ended December 31, 2000 and reports strong progress in the company’s business

The company reiterated its accelerated progress in the Phase II clinical
trials for DUROS sufentanil and announced that it expects to complete patient
enrollment before the end of second quarter 2001, which is approximately two
months ahead of its previous timelines. The company estimates that a number
of physicians active in the Phase II trial will also enroll participants in
the Phase III trial, with a number of potential patients already identified
for treatment. During the first half of 2001, DURECT will begin discussions
with a major pharmaceutical company for a U.S. and Canada distribution
relationship and has already initiated conversations with potential marketing
partners outside of the U.S.

DURECT has completed the development of a prototype clinical system for
its second product in development, a DUROS-based pharmaceutical system for the
delivery of hydromorphone to the spine for the treatment of end stage cancer
pain. End-stage cancer pain is a market segment that is not served by
commercially available implanted pumps today. The company’s product is being
developed to fit the clinical practice of the oncologist. DURECT has
finalized the company’s pharmaceutical formulation for the product and is
beginning preparation of its IND filing with plans to move the product into
the clinic in the second half of 2001.

DURECT also announced that the construction of its manufacturing facility
is on schedule with most of the mechanical work complete. The new facility
will comprise approximately 8,000 square feet and will be located at DURECT’s
headquarters in Cupertino, CA. DURECT has implemented a number of improved
efficiencies and automated procedures to greatly enhance the DUROS
manufacturing process. The Company believes the new DUROS manufacturing
process is more streamlined and efficient and believes should increase
production rates and clinical batch output. DURECT plans to manufacture Phase
III clinical batches and FDA registration batches for DUROS sufentanil from
the facility. The facility is designed to house a state-of-the-art aseptic
cleanroom space, an advanced manufacturing process capable of supporting clean
assembly and an automated aseptic filling operation. DURECT expects the
facility to have sufficient manufacturing capacity to provide commercial
quantities of the company’s lead product, as well, the facility is planned to
have a flexible, modular design to produce clinical supplies for future
products under development by the company. DURECT expects to complete the
construction of this facility in the first half of 2001 and validation by the
second half of 2001.

DURECT continues to make progress on the research side in a number of
other therapeutic areas and plans to move its third program into product
development before the end of 2001.

On a pro forma basis, DURECT’s net loss for the three months ended
December 31, 1999 was $3.3 million, or 11 cents per share. For the year ended
December 31, 2000, DURECT’s net loss was $20.8 million, or $1.22 per share,
compared to a net loss of $9.3 million, or $1.76 per share, for the year ended
December 31, 1999. On a pro forma basis, the net loss for the year ended
December 31, 2000 was $19.9 million, or 54 cents per share, compared to a net
loss of $8.7 million, or 37 cents per share, for the year ended December 31,

The increase in net loss for 2000 compared to the net loss in 1999 was
primarily due to, but not limited to, the company’s preparation for and
commencement of Phase II clinical trials for the company’s lead product, DUROS
sufentanil, for the treatment of chronic pain, completing the prototype design
of the company’s second product in development, DUROS hydromorphone for
terminal cancer pain, and research activities aimed at broadening the
technology base and identifying new product opportunities.

The Company also announced that its 2000 Annual Meeting of Stockholders
has been scheduled for June 27, 2001.

“We are pleased with the company’s progress over the past year. For the
year 2000, we met our key company milestones, including commencement of Phase
II clinical trials for our lead product, beginning construction on our
commercial manufacturing facility, and completing a prototype design for our
spinal delivery program for our second product, DUROS hydromorphone for
end-stage cancer pain. We completed two financings, including an initial
public offering of DURECT common stock, which together raised net proceeds of
approximately $109 million,” said James E. Brown, President and Chief
Executive Officer of DURECT. “We are also very pleased at the progress that
we have made in 2001 with our patient enrollment for our Phase II trial for
DUROS sufentanil. The accelerated pace exceeds our expectations, and we
expect this trial to complete ahead of the previously anticipated schedule.”

DURECT Corporation is pioneering the development and commercialization of
pharmaceutical systems to deliver the right drug to the right site in the
right amount at the right time. DURECT’s pharmaceutical systems combine
technology innovations from the medical device and drug delivery industries
with proprietary pharmaceutical and biotechnology drug formulations. These
capabilities can enable new drug therapies or optimize existing therapies
based on a broad range of compounds, including small molecule pharmaceuticals
as well as biotechnology molecules such as proteins, peptides and genes.
DURECT’s initial portfolio of products combine the DUROS technology, a proven
and patented drug delivery platform licensed for specified fields of use from
ALZA Corporation, with drugs for which medical data on efficacy and safety are

DURECT’s lead product in development, DUROS sufentanil, is for the
treatment of chronic pain. DUROS sufentanil is designed to deliver sufentanil
on a continuous basis for 3 months for the treatment of chronic pain. Annual
sales of opioids for the treatment of chronic pain are in excess of
$1 billion. DURECT’s second product, DUROS hydromorphone, is a DUROS-based
pharmaceutical system for the delivery of hydromorphone to the spine for the
treatment of end stage cancer pain. DURECT is also selling FDA cleared
catheters for the delivery of fluids to the inner ear. DURECT also
manufactures, sells and distributes the ALZET(R) osmotic pump product for use
in laboratory research.

Founded in 1998, the Company is headquartered in Cupertino, CA. The
Company’s World Wide Web site can be accessed at http://www.www.durect.com. To
join DURECT’s email alert service, please register by selecting “Email Alerts”
on the main Investor Relations web page at http://www.www.durect.com.

DUROS is a registered trademark of ALZA Corporation.

The statements in this press release regarding DURECT’s products in
development, product development plans, clinical trials, and expected product
benefits are forward-looking statements involving risks and uncertainties that
could cause actual results to differ materially from those in such
forward-looking statements. Potential risks and uncertainties include, but are
not limited to, DURECT’s ability to develop, manufacture and commercialize its
products, complete successful clinical trials, obtain product approvals from
regulatory agencies, build a manufacturing facility, marketplace acceptance of
DURECT’s products and DURECT’s ability to manage its growth and costs.
Further information regarding these and other risks is included in the
company’s S-1 registration statement, filed with the SEC on September 22, 2000
and its 424(b) prospectus filed with the SEC on September 28, 2000 and its
Quarterly Report on Form 10Q for the quarter ended September 30, 2000 filed
with the SEC on November 13, 2000.

For further information please contact:

DURECT Corporation

Schond L. Greenway Director, Investor Relations

Phone: (408) 777-1417


CONTACT: Schond L. Greenway Director, Investor Relations of DURECT
Corporation, 408-777-1417, schond.greenway@durect.com/

Scroll to Top