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.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.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:|
|Schond L. Greenway|
|Director, Investor Relations|
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/