CUPERTINO, Calif., Apr 24, 2002 /PRNewswire-FirstCall via COMTEX/ — DURECT
Corporation (Nasdaq: DRRX) announced today financial results for the three
months ended March 31, 2002.
DURECT’s net loss for the three months ended March 31, 2002 was $9.7 million or
20 cents per share, compared to $4.9 million or 11 cents per share for the same
period in 2001. DURECT’s results for the three months ended March 31, 2002
included non-cash charges for the amortization of intangible assets and
stock-based compensation of $933,000, compared to $1.2 million for the same
period in 2001.
“DURECT has begun 2002 by continuing strong progress in our business,” stated
Dr. Jim Brown, CEO of DURECT. “To date, we have announced positive results from
our pilot phase III trial for our lead product, the CHRONOGESIC(TM) (sufentanil)
Pain Therapy System. In the trial, we successfully converted patients from the
Duragesic(R) product to the CHRONOGESIC product without observing
clinically-relevant side effects or adverse events. We are on track with our
goal to initiate our pivotal Phase III trials mid-year for the CHRONOGESIC
product.”
“We had significant progress in our R&D efforts this quarter,” stated Dr. Felix
Theeuwes, Chairman and CSO of DURECT. “In March, we announced that we had
entered into a collaboration with Cardinal Health to research and develop long
acting oral gel-cap products using our SABER(TM) Delivery System. The use of our
SABER core formulations in soft-gelatin capsules has the potential of expanding
the soft-gelatin capsule business into the controlled-release markets. We also
recently announced that we filed an investigational new drug application (IND)
with the FDA to investigate the delivery of cromolyn sodium for the treatment of
asthma and allergic rhinitis (seasonal allergies) utilizing one of the Company’s
proprietary biodegradable drug delivery platforms.”
Research and development expenses were $8.0 million in the three months ended
March 31, 2002, compared to $4.1 million for the same period in 2001. The
increase was primarily attributable to expanded research and development
activities, especially related to preparation for the company’s pivotal Phase
III clinical trials for its lead product, CHRONOGESIC. The increase was also
attributable to continued investments in the research and development of other
pharmaceutical systems and the hiring of additional research and development
personnel.
Selling, general and administrative expenses were $2.3 million in the three
months ended March 31, 2002, compared to $1.9 million for the same period in
2001. The increase was primarily due to the expansion of corporate
infrastructure to support the growth in all areas of DURECT’s business.
At March 31, 2002, DURECT had cash and investments of $67.4 million, including
$3.4 million in restricted investments.
DURECT expects its net loss for the second quarter of 2002 to be in the range of
$10.5 million to $11.0 million or 22 to 23 cents per share. DURECT’s estimates
include non-cash charges for the amortization of intangible assets and
stock-based compensation of approximately $800,000 for the second quarter of
2002.
DURECT Corporation (www.www.durect.com) is pioneering the development and
commercialization of pharmaceutical systems for the treatment of chronic
debilitating diseases and enabling biotechnology-based pharmaceutical products.
DURECT’s goal is to deliver the right drug to the right site in the right amount
at the right time. DURECT’s lead product in development, the CHRONOGESIC(TM)
(sufentanil) Pain Therapy System, a 3-month product for the treatment of chronic
pain, completed a pilot phase III study in December 2001. DURECT owns three
proprietary drug delivery platform technologies, including the SABER(TM)
Delivery System (a patented and versatile depot injectable useful for protein
delivery), the MICRODUR(TM) Biodegradable Microparticulates (microspheres
injectable system) and the DURIN(TM) Biodegradable Implant (drug-loaded implant
system).
CHRONOGESIC(TM) is a trademark of DURECT Corporation. SABER(TM), MICRODUR(TM)
and DURIN(TM) are trademarks of Southern BioSystems, Inc., a wholly owned
subsidiary of DURECT Corporation. Other trademarks referred to belong to their
respective owners.
The statements in this press release regarding DURECT’s products in development,
expected product benefits, product development plans, future clinical trials,
potential product markets or projected future financial results are
forward-looking statements involving risks and uncertainties that can 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 research, develop, manufacture and commercialize its
products, obtain product and manufacturing approvals from regulatory agencies,
manage its growth and expenses, finance its activities and operations, as well
as marketplace acceptance of DURECT’s products. Further information regarding
these and other risks is included in DURECT’s Annual Report on Form 10-K for the
fiscal year ended December 31, 2001 filed with the SEC on March 28, 2002, under
the heading “Factors that may affect future results,” and other periodic reports
filed with the SEC. CHRONOGESIC is under development by DURECT and has not been
submitted or approved for commercialization by the US Food and Drug
Administration or other health authorities.
DURECT CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
Three months ended
March 31,
2002 2001
(unaudited) (unaudited)
Revenue, net $1,624 $1,399
Cost of goods sold (1) 779 611
Gross profit 845 788
Operating expenses:
Research and development 7,983 4,094
Research and development to
related party 12 47
Selling, general and
administrative 2,323 1,878
Amortization of intangible
assets 335 274
Stock-based compensation (1) 569 935
Total operating expenses 11,222 7,228
Loss from operations (10,377) (6,440)
Other income (expense):
Interest income 711 1,584
Interest expense (83) (62)
Net other income 628 1,522
Net loss $(9,749) $(4,918)
Net loss per share, basic and diluted $(0.20) $(0.11)
Shares used in computing basic and
diluted net loss per share 47,782 45,128
(1) Stock-based compensation related to the following:
Cost of goods sold $29 $22
Research and development 394 680
Selling, general and administrative 175 255
Total stock-based compensation $598 $957
DURECT CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEET
(in thousands)
March 31, December 31,
2002 2001*
(unaudited)
Assets
Current assets:
Cash, cash equivalents and short-term
investments $55,285 $55,204
Inventories and other current assets 4,407 5,007
Total current assets 59,692 60,211
Property and equipment, net 13,449 13,136
Intangible assets, net 9,842 10,178
Long-term investments and other non-
current assets 12,068 21,418
Total assets $95,051 $104,943
Liabilities and stockholders' equity
Current liabilities:
Accounts payable and accrued
liabilities $4,660 $5,065
Long-term obligations, current
portion 573 683
Total current liabilities 5,233 5,748
Long-term obligations, noncurrent
portion 2,140 2,147
Stockholders' equity 87,678 97,048
Total liabilities and stockholders'
equity $95,051 $104,943
(*) Derived from audited financial statements.
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SOURCE DURECT Corporation
CONTACT:
Schond L. Greenway, Senior Director, Investor Relations and
Strategic Planning of DURECT Corporation, +1-408-777-1417, or
schond.greenway@durect.com
URL: http://www.www.durect.com
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