CUPERTINO, Calif., Nov. 13 /PRNewswire/ — DURECT Corporation
(Nasdaq: DRRX) today announced financial results for the three months ended
September 30, 2000.
DURECT’s net loss attributable to common stockholders for its third
quarter ended September 30, 2000 was $6.0 million dollars, or $0.62 cents per
diluted share, compared to a net loss of $2.4 million dollars, or $0.43 cents
per diluted share, for the same period last year. On a pro forma basis,
DURECT’s net loss for its third quarter ended September 30, 2000 was
$5.7 million dollars, or $0.16 cents per diluted share, compared to a net loss
of $2.1 million dollars, or $0.08 cents per diluted share, for the same period
last year. Pro forma calculations assume the conversion of all preferred
stock, at the date of issuance, into common stock. DURECT’s pro forma net
loss excluding the effects of certain non-cash and stock-related charges was
$4.1 million, or $0.11 per diluted share, compared with $2.0 million, or
$0.07 per diluted share during the third quarter of 1999. DURECT’s results
include non-cash charges for the amortization of intangibles and stock-based
compensation of $1.7 million for the third quarter ended September 30, 2000.
The increase in net loss for the three months ended September 30, 2000
compared to the same period in 1999 were due primarily to increases in
research and development expenses, selling, general and administrative
expenses and non-cash items including amortization and stock-based
compensation. The increase in research and development expenses was
attributable to increases in contract research and development services,
research and development personnel and related payroll, and activity related
to the preparation for DURECT’s Phase II clinical trials for DUROS sufentanil,
including the manufacturing of product to be used in the trial. The increase
in selling, general and administrative expenses was primarily due to an
increase in general and administrative personnel and related expenses
necessary to support DURECT’s growth. Non-cash charges, including stock-based
compensation expenses and amortization expenses related to DURECT’s
acquisition of the ALZET and IntraEAR businesses also contributed to losses
this quarter.
At the end of the third quarter, the Company had cash and cash
equivalents, including short-term investments, that totaled $23.7 million
dollars, compared to $16.6 million dollars as of December 31st, 1999. This
increase was primarily due to the proceeds from the sale of preferred stock.
DURECT also recorded a receivable of $78.1 million for the proceeds from its
initial public offering, which closed on October 3rd, 2000.
Commenting on third quarter results, James E. Brown, D.V.M., President and
Chief Executive Officer, stated, “We are pleased to report progress with
respect to our business, particularly with respect to our product development
efforts. We have completed the development of a prototype clinical system for
our second product in development, a DUROS-based pharmaceutical system for the
delivery of hydromorphone to the spine for the treatment of terminal cancer
pain. We are also continuing to make progress towards beginning our Phase II
clinical trials for our DUROS sufentanil product.”
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
available. 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.
DURECT CORPORATION
(a development stage company)
CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
(Unaudited)
Three months ended Nine Months ended
Sept. 30, Sept. 30,
2000 1999 2000 1999
Revenues, net $1,101 $-- $2,182 $--
Cost of goods sold 777 -- 1,417 --
Gross margin 324 -- 765 --
Operating expenses:
Research and development 3,400 1,371 8,648 3,112
Research and development
to related party 193 166 626 861
Selling, general and
administrative 1,472 644 3,710 1,465
Stock-based compensation 1,432 125 3,932 351
Total operating expenses 6,497 2,306 16,916 5,789
Loss from operations (6,173) (2,306) (16,151) (5,789)
Other income (expense):
Interest income 495 234 1,322 375
Interest expense (34) (10) (88) (20)
Net other income 461 224 1,234 355
Net Loss (5,712) (2,082) (14,917) (5,434)
Accretion of cumulative
dividends on Series B
convertible preferred stock 319 271 972 271
Net loss attributable
to common stockholders $(6,031) $(2,353) $(15,889) $(5,705)
Net loss per common share,
basic and diluted $(0.62) $(0.43) $(1.96) $(1.13)
Shares used in computing
basic and diluted
net loss per share 9,803 5,522 8,118 5,054
Pro forma net loss
per share,
basic and diluted(1) $(0.16) $(0.08) $(0.44) $(0.25)
Shares used in computing
pro forma net loss
per share(1) 36,408 27,194 34,170 21,719
(1) Pro forma calculations assume the conversion of all preferred stock,
at the date of issuance, into common stock.
DURECT CORPORATION
(a development stage company)
CONDENSED BALANCE SHEETS
(in thousands, except per share amounts)
Sept. 30, Dec. 31,
2000 1999
(unaudited)
Assets
Current assets:
Cash and cash equivalents $19,320 $3,863
Short-term investments 4,372 12,735
IPO proceeds receivable 78,120 --
Accounts receivable, net 851 97
Inventories 3,096 188
Prepaid expenses and other current assets 1,015 584
Total current assets 106,774 17,467
Property and equipment, net 2,272 1,271
Intangible assets, net 5,449 1,390
Long-term investments 1,642 2,335
Total assets $116,137 $22,463
Liabilities and stockholders' equity
Current liabilities:
Accounts payable $347 $483
Accrued liabilities 905 429
Accrued liabilities to related party 1,050 321
Accrued stock issuance cost 575 --
Contract research liability 406 180
Equipment financing obligations, current portion 326 133
Total current liabilities 3,609 1,546
Equipment financing obligations,
noncurrent portion 923 189
Commitments and contingencies
Stockholders' equity:
Preferred stock -- 2
Common stock 4 1
Additional paid-in capital 158,145 34,642
Notes receivable from stockholders (652) (33)
Accumulated other comprehensive income (loss) (2) --
Deferred compensation (5,889) (3,252)
Deferred royalties and commercial rights (13,480) --
Deficit accumulated during the
development stage (26,521) (10,632)
Stockholders' equity 111,605 20,728
Total liabilities and stockholders' equity $116,137 $22,463
| CONTACT: | For further information please contact: |
|---|---|
| DURECT Corporation | |
| Schond L. Greenway | |
| Director, Investor Relations | |
| Phone: 408-777-1417 | |
| Schond.Greenway@Durect.com |
Noonan/Russo Communications
Tom Baker
Media Relations
Phone: 415-677-4455, ext. 370
T.Baker@NoonanRusso.com
SOURCE DURECT Corporation
CONTACT: Schond L. Greenway, Director, Investor Relations, DURECT
Corporation, 408-777-1417, Schond.Greenway@Durect.com; Media – Tom Baker of
Noonan-Russo Communications, 415-677-4455, ext. 370, T.Baker@NoonanRusso.com,
for DURECT Corporation/