VNDA Vanda Pharmaceuticals Inc

ROCKVILLE, Md., Feb. 11 /PRNewswire-FirstCall/ -- Vanda Pharmaceuticals Inc. (NASDAQ:VNDA), a biopharmaceutical company focused on the development and commercialization of clinical-stage product candidates for central nervous system disorders, today announced financial and operational results for the fourth quarter ended December 31, 2008. Vanda reported a net loss of $7.5 million for the fourth quarter of 2008, compared to $10.9 million for the third quarter of 2008 and $20.7 million for the fourth quarter of 2007. Total expenses for the fourth quarter of 2008 were $7.7 million, compared to $11.2 million for the third quarter of 2008 and $22.0 million for the fourth quarter of 2007. Research and development (R&D) expenses for the fourth quarter of 2008 were $3.6 million, compared to $3.8 million for the third quarter of 2008 and $12.6 million for the fourth quarter of 2007. The decrease in R&D expenses in the fourth quarter of 2008 relative to the third quarter of 2008 is primarily due to the decrease in stock-based compensation expense for R&D personnel due to the cancellation of unvested options. The decrease in R&D expenses in the fourth quarter of 2008 relative to the fourth quarter of 2007 is attributable to lower clinical trial costs in 2008 compared to costs from trials conducted in 2007. For the full year of 2008, total expenses were $52.8 million, compared to $80.0 million for 2007. Total 2008 R&D expenses were $23.9 million compared to $47.2 million during 2007. As of December 31, 2008, Vanda's cash, cash equivalents, and marketable securities totaled approximately $46.5 million. As of December 31, 2008, a total of approximately 26.7 million shares of Vanda common stock were outstanding. Net loss per common share for the fourth quarter of 2008 was $0.28, compared to $0.41 for the third quarter of 2008 and $0.78 for the fourth quarter of 2007. OPERATIONAL HIGHLIGHTS On November 6, 2008, Vanda submitted a Complete Response to the not approvable action letter that the Company received from the U.S. Food and Drug Administration (FDA) on July 25, 2008 regarding iloperidone. The FDA has indicated that it has accepted the Complete Response for review and has set a new target action date of May 6, 2009. Pending a response from the FDA, Vanda is concentrating its efforts on the design and evaluation of clinical development options for tasimelteon, its compound for sleep and mood disorders. Results of prior phase II and III clinical trials for tasimelteon were published in the December 2008 issue of The Lancet. On December 16, 2008, Vanda announced a workforce reduction of 17 employees, including two officers. FINANCIAL DETAILS -- Operating Expenses. Fourth quarter 2008 R&D expenses, primarily consisting of salaries and related costs of R&D personnel, including $0.6 million of severance expense and the costs of regulatory consultants, totaled $3.6 million, compared to $3.8 million for the third quarter of 2008 and $12.6 million for the fourth quarter of 2007. The decrease in R&D expenses in the fourth quarter of 2008 relative to the third quarter of 2008 is primarily due to the decrease in stock-based compensation expense for R&D personnel due to the cancellation of unvested options in connection with the workforce reduction. The decrease in R&D expenses in the fourth quarter of 2008 relative to the fourth quarter of 2007 is primarily attributable to lower clinical trial costs in the fourth quarter of 2008 compared to the costs from trials conducted in the fourth quarter of 2007. For the full year of 2008, total R&D expenses were $23.9 million, compared to $47.2 million for the full year of 2007. Lower R&D expenses resulted from the lower clinical trial costs and related manufacturing costs incurred in 2008. General and administrative (G&A) expenses totaled $4.1 million for the fourth quarter of 2008, compared to $7.4 million for the third quarter of 2008 and $9.5 million for the fourth quarter of 2007. The decrease in G&A expenses in the fourth quarter of 2008 relative to the third quarter of 2008 is primarily due to lower iloperidone pre-commercial launch expenses and the decrease in stock-based compensation expense for G&A personnel due to the cancellation of unvested options in connection with the workforce reduction offset by $1.0 million of severance expense. The decrease in G&A expenses in the fourth quarter of 2008 relative to the fourth quarter of 2007 is primarily due to lower employee stock-based compensation expense and lower iloperidone pre-commercial launch expenses. For the full year of 2008, total G&A expenses were $28.9 million, compared to $32.8 million for the prior year. The year-over-year decrease in G&A expenses is primarily due to decreased stock-based compensation expense and decreased business and commercial development expenses. Employee stock-based compensation expense recorded in the fourth quarter of 2008 totaled $0.7 million. Of these non-cash charges, $0.6 million was recorded as a reversal R&D expense and $1.3 million was recorded as G&A expense. For the third quarter of 2008 and the fourth quarter of 2007, total stock-based compensation was $3.6 million and $5.2 million, respectively. The decrease in stock-based compensation in the fourth quarter of 2008 relative to the third quarter of 2008 is the result of the net effect of stock-based compensation for the period for existing employees reduced by the reversal of stock-based compensation charges resulting from the cancellation of unvested options in connection with the workforce reduction. The decrease in stock-based compensation in the fourth quarter of 2008 relative to the fourth quarter of 2007 is primarily due to the lower fair market value of options granted in 2008 and the reversal of cumulative amortization of deferred stock-based compensation related to the cancellation of unvested options in connection with the workforce reduction. For the full year of 2008, total stock-based compensation was $13.4 million, compared to $19.5 million for the prior year. -- Net loss for the fourth quarter of 2008 was $7.5 million, compared to a net loss of $10.9 million for the third quarter of 2008 and $20.7 million for the fourth quarter of 2007. For the full year of 2008, net loss was $51.1 million, compared to $74.1 million for the full year of 2007. -- Net loss per common share for the fourth quarter of 2008 was $0.28, compared to $0.41 for the third quarter of 2008 and $0.78 for the fourth quarter of 2007. For the full year of 2008, net loss per common share was $1.92, compared to $2.81 for the full year of 2007. -- Cash and marketable securities decreased by $5.2 million during the fourth quarter of 2008. Changes included $7.5 million of net losses, decreases in accrued R&D expenses and accounts payable of $0.6 million, offset by decreases in prepaid expenses of $1.7 million, $0.8 million in non-cash depreciation, amortization, and stock-based compensation expenses and net decreases in other working capital of $0.4 million. -- Vanda's cash, cash equivalents and marketable securities as of December 31, 2008 totaled approximately $46.5 million, compared to approximately $51.7 million as of September 30, 2008 and $93.2 million as of December 31, 2007. FINANCIAL GUIDANCE Vanda expects its operating cash spend to be approximately $3.8 million for the first quarter of 2009, including $0.8 million for severance payments. The projected $3 million of non-severance costs include administrative overhead, personnel costs, costs to complete an ongoing carcinogenicity study and regulatory consulting fees. ABOUT VANDA PHARMACEUTICALS INC.: Vanda Pharmaceuticals Inc. is a biopharmaceutical company focused on the development and commercialization of clinical-stage product candidates for central nervous system disorders. For more on Vanda Pharmaceuticals Inc., please visit http://www.vandapharma.com/. CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS Various statements in this release are "forward-looking statements" under the securities laws. Words such as, but not limited to, "believe," "expect," "anticipate," "estimate," "intend," "plan," "targets," "likely," "will," "would," and "could," and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Vanda is at an early stage of development and may not ever have any products that generate significant revenue. Important factors that could cause actual results to differ materially from those reflected in the company's forward-looking statements include, among others: delays in the completion of Vanda's clinical trials; a failure of Vanda's product candidates to be demonstrably safe and effective; Vanda's failure to obtain regulatory approval for its products or to comply with ongoing regulatory requirements; a lack of acceptance of Vanda's product candidates in the marketplace, or a failure to become or remain profitable; Vanda's inability to obtain the capital necessary to fund its research and development activities; Vanda's failure to identify or obtain rights to new product candidates; Vanda's failure to develop or obtain sales, marketing and distribution resources and expertise or to otherwise manage its growth; a loss of any of Vanda's key scientists or management personnel; losses incurred from product liability claims made against Vanda; a loss of rights to develop and commercialize Vanda's products under its license and sublicense agreements and other factors that are described in the "Risk Factors" section (Part II, Item 1A) of Vanda's quarterly report on Form 10-Q for the quarter ended September 30, 2008 (File No. 000-51863). In addition to the risks described above and in Part II, Item 1A of Vanda's quarterly report on Form 10-Q, other unknown or unpredictable factors also could affect Vanda's results. There can be no assurance that the actual results or developments anticipated by Vanda will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Vanda. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved. All written and verbal forward-looking statements attributable to Vanda or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Vanda cautions investors not to rely too heavily on the forward-looking statements Vanda makes or that are made on its behalf. The information in this release is provided only as of the date of this release, and Vanda undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise. VANDA PHARMACEUTICALS INC. (A Development Stage Enterprise) CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) Three Months Ended Year Ended Dec. 31, Dec. 31, Dec. 31, Dec. 31, 2008 2007 2008 2007 Revenues from services $- $- $- $- Operating expenses: Research and development 3,559,543 12,574,735 23,935,541 47,234,867 General and administrative 4,095,118 9,472,938 28,909,580 32,803,508 Total operating expenses 7,654,661 22,047,673 52,845,121 80,038,375 Loss from operations (7,654,661) (22,047,673) (52,845,121) (80,038,375) Interest income 150,642 1,299,076 1,780,880 5,907,219 Other income - - - 71,345 Total other income, net 150,642 1,299,076 1,780,880 5,978,564 Loss before tax provision (7,504,019) (20,748,597) (51,064,241) (74,059,811) Tax provision - (191) - 9,879 Net loss $(7,504,019) $(20,748,406) $(51,064,241) $(74,069,690) Basic and diluted net loss per share attributable to common stockholders $(0.28) $(0.78) $(1.92) $(2.81) Shares used in calculation of basic and diluted net loss per share attributable to common stockholders 26,652,187 26,644,540 26,650,126 26,360,177 VANDA PHARMACEUTICALS INC. (A Development Stage Enterprise) CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) December 31, December 31, 2008 2007 ASSETS Current assets: Cash and cash equivalents $39,079,304 $41,929,533 Marketable securities 7,378,798 43,243,960 Prepaid expenses, deposits and other current assets 1,287,400 1,781,881 Total current assets 47,745,502 86,955,374 Marketable securities, long-term - 7,979,331 Property and equipment, net 1,758,111 1,345,845 Deposits - 150,000 Restricted cash 430,230 430,230 Total assets $49,933,843 $96,860,780 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $512,382 $2,988,069 Accrued expenses 2,898,417 9,789,738 Total current liabilities 3,410,799 12,777,807 Long-term liabilities: Deferred rent 502,770 354,042 Total liabilities 3,913,569 13,131,849 Stockholders' equity: Common stock 26,653 26,653 Additional paid-in capital 270,988,157 257,600,368 Accumulated other comprehensive income (loss) (20,029) 12,176 Deficit accumulated during the development stage (224,974,507) (173,910,266) Total stockholders' equity 46,020,274 83,728,931 Total liabilities and stockholders' equity $49,933,843 $96,860,780 VANDA PHARMACEUTICALS INC. (A Development Stage Enterprise) CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) Year Ended December 31, December 31, 2008 2007 Cash flows from operating activities: Net loss $(51,064,241) $(74,069,690) Adjustments to reconcile net income to net cash used in operating activities: Depreciation and amortization 530,805 571,586 Stock-based compensation 13,387,789 19,622,814 Loss on disposal of assets (173) 28,713 Accretion of discount on investments (235,163) (1,571,905) Changes in assets and liabilities: Prepaid expenses and other current assets 495,200 168,987 Deposits 150,000 - Accounts payable (2,475,697) 204,029 Accrued expenses (6,892,577) 3,465,028 Deferred grant revenue - (147,464) Other liabilities 148,728 86,644 Net cash used in operating activities (45,955,329) (51,641,258) Cash flows from investing activities: Purchases of property and equipment (943,659) (279,433) Proceeds from sales of property and equipment - 200,179 Purchases of marketable securities (14,786,080) (138,953,879) Proceeds from sales of marketable securities 11,258,094 3,577,859 Maturities of marketable securities 47,560,000 86,695,000 Net cash provided by (used in) investing activities 43,088,355 (48,760,274) Cash flows from financing activities: Proceeds from exercise of stock options and warrants - 148,640 Proceeds from issuance of common stock, net of issuance costs - 111,254,850 Net cash provided by financing activities - 111,403,490 Effect of foreign currency translation 16,745 (1,320) Net increase (decrease) in cash and cash equivalents (2,850,229) 11,000,638 Cash and cash equivalents, beginning of period 41,929,533 30,928,895 Cash and cash equivalents, end of period $39,079,304 $41,929,533 DATASOURCE: Vanda Pharmaceuticals Inc. CONTACT: Stephanie R. Irish, Acting Chief Financial Officer of Vanda Pharmaceuticals Inc., +1-240-599-4500, Web Site: http://www.vandapharma.com/

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