CUPERTINO, Calif., July 30 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) announced today financial results for the three months ended June 30, 2001.
The company's net loss attributable to common stockholders for the three months ended June 30, 2001 was $7.0 million or 15 cents per share (excluding a one-time, non-cash charge) compared to $5.2 million, or 65 cents per share, for the three months ended June 30, 2000. DURECT incurred a one-time non-cash charge of $14.0 million for acquired in-process research and development associated with the acquisition of Southern BioSystems, Inc. that was completed during the quarter. Including the one-time non-cash charge for acquired in-process research and development, the company's net loss was $21.0 million. DURECT's results for the period also include non-cash charges for the amortization of intangible assets and stock-based compensation of $1.4 million compared to $1.6 million for the same period in 2000.
"We are pleased with the company's progress over the quarter. We have completed our Phase II clinical trial for Chronogesic(TM) and completed construction of our commercial manufacturing facility. Each of these accomplishments represents a significant step towards initiating our Phase III clinical trial, and towards bringing our products to market. In addition, we received clearance for a special 510(k) pre-market notification with the FDA for our next generation ear delivery catheter. The cleared catheter is used by the Naval Medical Center San Diego as part of a blinded, placebo controlled study evaluating the use of gentamicin for the treatment of Meniere's disease," stated James E. Brown, CEO of DURECT. "We also announced our acquisition of Southern BioSystems. With this acquisition, we have added three additional drug delivery platforms, the SABER(TM) delivery system, microspheres and drug-loaded implants, which will allow us to move additional products into development. These technology platforms, which enable delivery of drugs from days to months, are very complementary to our existing DUROS(R) business, which has a therapeutic delivery profile from months to a year."
The increase in net loss in the second quarter of 2001 compared to the same quarter in 2000, excluding the one-time charge for acquired in-process research and development, was primarily due to increased research and development activity and selling, general and administrative expenses. The increase in research and development expenses was primarily attributable to the company's Phase II clinical trial for its lead product, Chronogesic(TM). 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. The increase in operating expenses was partially offset by increased interest income resulting from higher average outstanding cash and investment balances.
At June 30, 2001, the company had cash and investments of $94.2 million compared to $106.1 million at December 31, 2000.
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.
Chronogesic(TM) is a trademark of DURECT Corporation. IntraEAR(TM) is a registered trademark of DURECT Corporation. SABER(TM) is a trademark of Southern BioSystems, Inc., a subsidiary of DURECT Corporation. DUROS is a registered trademark of ALZA Corporation.
DURECT CORPORATION CONDENSED CONSOLIDATED BALANCE SHEET (in thousands) June 30, December 31, 2001 2000 (1) (unaudited) Assets Current assets: Cash, cash equivalents and short-term investments $68,715 $104,432 Inventories and other current assets 5,794 4,881 Total current assets 74,509 109,313 Property and equipment, net 10,527 4,472 Intangible assets, net 11,186 5,175 Long-term investments and other non- current assets 25,476 1,652 Total assets $121,698 $120,612 Liabilities and stockholders' equity Current liabilities: Accounts payable and accrued liabilities $4,947 $3,846 Other current liabilities 667 407 Total current liabilities 5,614 4,253 Other long term liabilities 2,498 1,105 Stockholders' equity 113,586 115,254 Total liabilities and stockholders' equity $121,698 $120,612
(1) Derived from audited financial statements.
DURECT CORPORATION CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except per share amounts)
Three months ended Six months ended June 30, June 30, 2001 2000 2001 2000 (unaudited)(unaudited)(unaudited)(unaudited)
Revenue, net $1,687 $998 $3,086 $1,081 Cost of goods sold (1) 974 575 1,585 611 Gross profit 713 423 1,501 470 Operating expenses: Research and development 5,315 2,983 9,409 5,242 Research and development to related party 18 171 65 433 Selling, general and administrative 2,157 1,003 4,035 1,973 Amortization of intangible assets 461 233 735 302 Stock-based compensation (1) 919 1,367 1,854 2,499 Acquired in-process research and development 14,030 -- 14,030 -- Total operating expenses 22,900 5,757 30,128 10,449 Loss from operations (22,187) (5,334) (28,627) (9,979) Other income (expense): Interest income 1,281 540 2,864 828 Interest expense (84) (33) (145) (55) Net other income 1,197 507 2,719 773 Net loss (20,990) (4,827) (25,908) (9,206) Accretion of cumulative dividends on Series B convertible -- 326 -- 653 preferred stock Net loss attributable to common stockholders $(20,990) $(5,153) $(25,908) $(9,859) Net loss per common share, basic and diluted $(0.45) $(0.65) $(0.57) $(1.35) Shares used in computing basic and diluted net loss per share 46,325 7,958 45,726 7,279 Pro forma net loss attributable to common stockholders excluding acquired in-process research & development $(6,960) $(11,878) Pro forma net loss per share, basic and diluted excluding acquired in-process research & development $(0.15) $(0.26) Shares used in computing pro forma net loss per share 46,325 45,726 (1) Stock-based compensation related to the following: Cost of goods sold $65 $21 $87 $21 Research and development 613 960 1,294 1,665 Selling, general and administrative 306 407 560 834 $984 $1,388 $1,941 $2,520
The statements in this press release regarding DURECT's products in development, product development plans, or 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, successfully complete clinical trials, obtain product and manufacturing approvals from regulatory agencies, and validate and qualify a manufacturing facility, as well as marketplace acceptance of DURECT's products. 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, 424(b) prospectus filed with the SEC on September 28, 2000, Quarterly Report on Form 10-Q for the quarter ended April 30, 2001 filed with the SEC on May 11, 2001 and Annual Report on Form 10-K for the fiscal year ended December 31, 2000 filed with the SEC on March 30, 2001.
|Contact:||Schond L. Greenway, Director, Investor Relations of DURECT|
|Corporation, 408-777-1417, firstname.lastname@example.org.|
SOURCE DURECT Corporation
CONTACT: Schond L. Greenway, Director, Investor Relations of DURECT Corporation, +1-408-777-1417, email@example.com./