CUPERTINO, Calif., July 27 /PRNewswire-FirstCall/ — DURECT Corporation
(Nasdaq: DRRX) announced today financial results for the three months ended
June 30, 2006.
(Logo: http://www.newscom.com/cgi-bin/prnh/20020717/DRRXLOGO )
DURECT’s net loss for the three months ended June 30, 2006 was $8.7
million or 14 cents per share, compared to a net loss of $3.6 million or 7
cents per share for the same period in 2005. DURECT’s results for the three
months ended June 30, 2006 included non-cash charges for the amortization of
intangible assets and stock-based compensation of $1.1 million, compared to
$646,000 for the same period in 2005. Cash used in operating activities was
$10.2 million for the three months ended June 30, 2006, compared to $4.8
million of cash provided by operating activities for the same period in 2005,
which included a $10.0 million payment from Endo Pharmaceuticals in connection
with our license agreement for the TRANSDUR(TM)-Sufentanil product for the
U.S. and Canadian markets.
“We continued to drive forward our development programs and build value
for our shareholders in the first half of 2006. During the second quarter, we
expanded the development of our POSIDUR(TM) product (formerly referred to as
SABER(TM)-Bupivacaine), into five on-going Phase II clinical trials. We are
conducting these studies in the U.S. and other countries in a variety of soft-
tissue and orthopedic surgery models for the purpose of selecting the optimal
dosing and the pain models to be used for our pivotal Phase III trials,” said
James E. Brown, D.V.M., President and CEO of DURECT.
Dr. Brown continued, “We are also pleased with development progress of
Remoxy, an abuse-resistant, long-acting, oral pain medication, which is
currently undergoing a Special Protocol Assessment approved Phase III study.
We are currently working with King Pharmaceuticals and Pain Therapeutics to
advance the 2nd ORADUR(TM) abuse-resistant opioid product into the clinic
later this year.
We are excited about the accelerated pace of our TRANSDUR(TM)-Sufentanil
development program. Our partner, Endo Pharmaceuticals, intends to conduct a
Phase II program with multiple studies in parallel in 2006. We are currently
supplying additional Phase II clinical product for this program and Endo has
secured the Phase III clinical and commercial manufacturing capacity necessary
for this product.
Our partner, Voyager Pharmaceuticals, recently announced positive data
from a Phase II clinical study in men and presented a poster at the 10th
International Conference on Alzheimer’s Disease and Related Disorders. Voyager
also completed enrollment for the first 550-patient clinical study for its
ongoing Phase III program and enrollment for the second 550-patient clinical
study is currently underway. Going forward, we will continue to provide
clinical product and support the on-going Phase III clinical program.
During the second quarter, we reduced our long-term debt by approximately
35% by converting $20 million of our outstanding convertible notes on
favorable terms, which strengthened our financial position.”
Total revenues were $6.1 million for the three months ended June 30, 2006,
compared to $8.8 million for the same period in 2005. Total collaborative
research and development and other revenues were $4.0 million for the three
months ended June 30, 2006, compared with $6.9 million for the same period in
2005. The decrease in total revenues is primarily attributable to lower
collaborative research and development revenue recognized from our agreements
with Voyager Pharmaceutical Corporation and Endo Pharmaceuticals, Inc., with
the advancement of these programs into later stage development, offset by
higher research and development revenue from Pain Therapeutics, Inc. due to
the increased development activities for Remoxy and the second ORADUR opioid
product, and higher product revenues from our ALZET product lines.
Research and development expenses were $8.5 million for the three months
ended June 30, 2006, compared to $7.6 million for the same period in 2005.
The increase was primarily attributable to higher employee cost related to R&D
personnel and the stock-based compensation expense of $697,000 related to
research and development personnel recognized under SFAS 123(R) (Share-based
Payments) in the second quarter of 2006.
Selling, general and administrative expenses were $3.2 million for the
three months ended on both June 30, 2006 and 2005. Selling, general and
administrative expenses included $323,000 in stock-based compensation expense
recognized under SFAS 123(R) for the three months ended June 30, 2006. We
continued to maintain existing corporate infrastructure to support the growth
in all areas of DURECT’s business.
Interest and other income was $978,000 for the three months ended June 30,
2006, compared with $407,000 for the same period in 2005. The increase in
interest income was primarily the result of higher yields as well as higher
average cash and investment balances during the three months ended June 30,
2006 compared with the same period in 2005. Interest expense was $359,000 for
the three months ended June 30, 2006, compared with $1.1 million for the same
period in 2005. The decrease in interest expense in the second quarter of 2006
was primarily due to lower balance on our convertible notes resulting from the
conversion of $20 million in principal amount of the notes.
During the second quarter of 2006, we converted $20.0 million in principal
amount of our 6.25% Convertible Subordinated Notes into an aggregate of
6,349,206 shares of our common stock. In connection with this transaction, we
recorded debt conversion expense of approximately $2.9 million in the three
months ended June 30, 2006. As of June 30, 2006, the remaining principal
balance of our 6.25% Convertible Subordinated Notes due 2008 was $37.3
million.
At June 30, 2006, DURECT had cash and investments of $77.7 million,
including $1.5 million in restricted investments, compared with cash and
investments of $91.0 million at December 31, 2005.
About DURECT Corporation
DURECT Corporation is an emerging specialty pharmaceutical company focused
on the development of pharmaceutical systems based on its proprietary drug
delivery platform technologies. The company is developing pharmaceutical
systems to deliver the right drug to the right place in the right amount at
the right time to treat chronic and episodic diseases and conditions.
NOTE: POSIDUR(TM), SABER(TM), ORADUR(TM), DURIN(TM), TRANSDUR(TM) and
MICRODUR(TM) are trademarks of DURECT Corporation. Other referenced trademarks
belong to their respective owners.
DURECT Forward-Looking Statement
The statements in this press release regarding DURECT’s products in
development, product development plans and projected 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 (and that of its third party collaborators where applicable)
abilities to design, enroll, conduct and complete clinical trials, complete
the design, development, and manufacturing process development of the product
candidate, obtain product and manufacturing approvals from regulatory agencies
and manufacture and commercialize the product candidate, as well as
marketplace acceptance of the product candidate. Further information regarding
these and other risks is included in DURECT’s Annual Report on Form 10-K for
the year ended December 31, 2005 filed with the SEC on March 16, 2006 under
the heading “Risk Factors.”
DURECT CORPORATION
CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
Three months ended Six months ended
June 30, June 30,
2006 2005 2006 2005
(unaudited) (unaudited)(unaudited)(unaudited)
Collaborative research and
development and other
revenue $4,048 $6,930 $7,106 $10,527
Product revenue, net 2,060 1,889 4,213 3,646
Total revenues 6,108 8,819 11,319 14,173
Operating expenses:
Cost of revenues 770 689 1,599 1,360
Research and development 8,549 7,613 15,713 14,277
Selling, general and
administrative 3,189 3,155 6,194 5,663
Amortization of intangible
assets 94 303 394 606
Total operating expenses 12,602 11,760 23,900 21,906
Loss from operations (6,494) (2,941) (12,581) (7,733)
Other income (expense):
Interest and other income 978 407 1,884 892
Interest expense (359) (1,114) (1,436) (2,234)
Debt conversion expense (2,860) -- (2,860) --
Net other expense (2,241) (707) (2,412) (1,342)
Net loss $(8,735) $(3,648) $ (14,993) $(9,075)
Net loss per share, basic
and diluted $(0.14) $(0.07) $(0.24) $(0.17)
Shares used in computing basic
and diluted net loss per
share 64,207 52,047 63,040 51,967
(1) Stock-based compensation
related to the following:
Cost of revenues $18 $-- $26 $--
Research and development 697 -- 1,311 46
Selling, general and
administrative 323 343 644 347
$1,038 $343 $1,981 $393
DURECT CORPORATION
CONDENSED BALANCE SHEETS
(in thousands)
June 30, December 31,
2006 2005 (1)
Assets
Current assets:
Cash and cash equivalents $41,252 $65,542
Short-term investments 24,622 18,022
Restricted investments -- 321
Accounts Receivable 4,012 4,488
Inventories 2,104 2,047
Prepaid expenses and other current assets 3,171 3,659
Total current assets 75,161 94,079
Property and equipment, net 7,434 7,304
Goodwill 6,399 6,399
Intangible assets, net 141 536
Long-term investments 10,355 5,459
Restricted investments 1,507 1,653
Other non-current assets 1,183 1,984
Total assets $102,180 $117,414
Liabilities and stockholders' equity
Current liabilities:
Accounts payable, accrued liabilities and
deferred revenue $7,464 $9,643
Long-term obligations, current portion 232 234
Total current liabilities 7,696 9,877
Long-term obligations, noncurrent portion 43,322 64,185
Stockholders' equity 51,162 43,352
Total liabilities and stockholders' equity $102,180 $117,414
(1) Derived from audited financial statements.
SOURCE DURECT Corporation
07/27/2006
CONTACT: Schond L. Greenway, Vice President, Investor Relations and
Strategic Planning of DURECT Corporation, +1-408-777-1417
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Web site: http://www.www.durect.com
(DRRX)