ROCKVILLE, Md., Aug. 2 /PRNewswire-FirstCall/ -- Vanda Pharmaceuticals Inc. , 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 second quarter ended June 30, 2007.
Vanda reported research and development (R&D) expenses in the second quarter of 2007 of $10.2 million, compared to first quarter of 2007 R&D expenses of $10.6 million and second quarter of 2006 R&D expenses of $19.1 million. The decrease in R&D expenses in the second quarter of 2007 relative to the first quarter of 2007 is primarily attributable to lower clinical trial costs associated with the completion of the long-term open label portion of the Phase III trial for iloperidone. The decrease in R&D expenses in the second quarter of 2007 relative to the second quarter of 2006 was primarily due to lower clinical trial expenses for the company’s iloperidone and VEC-162 Phase III trials that were primarily completed in 2006. Total expenses for the second quarter of 2007 were $17.6 million, compared to $16.8 million in the first quarter of 2007 and $22.1 million in the second quarter of 2006.
Net loss applicable to common stockholders was $16.0 million for the second quarter of 2007, compared to $15.4 million in the first quarter of 2007 and $21.4 million in the second quarter of 2006. Net loss per share applicable to common stockholders for the second quarter of 2007 was $0.60, compared to $0.61 in the first quarter of 2007, and $1.11 in the second quarter of 2006.
As of June 30, 2007, Vanda’s cash, cash equivalents, and marketable securities totaled $119.7 million. As of June 30, 2007, the company had a total of approximately 26.6 million shares of common stock outstanding.
OPERATIONAL HIGHLIGHTS
Iloperidone
Vanda remains on track to file its New Drug Application (NDA) for iloperidone in schizophrenia by the end of this year. Development work continues on the 4-week injectable formulation of iloperidone. Vanda is also preparing to present Phase III safety and efficacy results for iloperidone, as well as related pharmacogenetics findings, at the American Society of Human Genetics conference in October and the American College of Neuropsychopharmacology conference in December.
VEC-162
Vanda continues preparatory work on the next Phase III clinical trial, to evaluate the safety and efficacy of VEC-162 in chronic primary insomnia. The trial is expected to be a randomized, double-blind, and placebo-controlled study, and will enroll approximately 400 patients. The trial will measure time to fall asleep and sleep maintenance, as well as next-day performance and mood. Patient dosing for the trial will begin in the fourth quarter of 2007.
VSF-173
On April 25, 2007, Vanda announced the initiation of a Phase II clinical trial for VSF-173 in excessive sleepiness. The trial is a randomized, double- blind, and placebo-controlled study to investigate the efficacy and safety of three oral doses of VSF-173 in treating induced excessive sleepiness in approximately 60 healthy volunteers. The primary endpoint of the study is the difference from placebo on the Maintenance of Wakefulness Test (MWT), a standard measure of sleepiness. As trial enrollment is now ahead of schedule, the company expects to announce top-line results for the trial in the fourth quarter of 2007.
FINANCIAL DETAILS -- Operating Expenses. Second quarter 2007 R&D expenses, primarily consisting of salaries and related costs of R&D personnel, stock-based compensation, and the costs of consultants, materials and supplies associated with the company’s clinical trials and research initiatives, were $10.2 million, down from $10.6 million in the previous quarter and down from $19.1 million in the second quarter of 2006. The decrease in R&D expenses in the second quarter of 2007 relative to the first quarter of 2007 was primarily due to lower clinical trial costs related to the completion of the long-term open label portion of the Phase III trial for iloperidone. The decrease in R&D expenses in the second quarter of 2007 relative to the second quarter of 2006 was primarily due to lower clinical trial expenses for the company’s iloperidone and VEC-162 Phase III trials that were primarily completed in 2006. General and administrative (G&A) expenses totaled $7.4 million in the second quarter of 2007, up from $6.2 million in the first quarter of 2007, and up from $3.0 million in the second quarter of 2006. The increase in G&A expenses in the second quarter of 2007 relative to both the first quarter of 2007 and the second quarter of 2006 was primarily due to increased stock-based compensation charges, salaries and related costs of non-R&D personnel, marketing, insurance, and facility expenses. Employee stock-based compensation expense recorded in the second quarter of 2007 was $5.1 million, or $0.19 per share. Of the total $5.1 million, $1.1 million was recorded in R&D expenses and $4.0 million was recorded in G&A expenses. In the first quarter of 2007 and the second quarter of 2006, total stock-based compensation was $4.0 million and $1.5 million, respectively. -- Net loss applicable to common stockholders for the second quarter of 2007 was $16.0 million. This compares to a net loss of $15.4 million in the first quarter of 2007, and $21.4 million in the second quarter of 2006. -- Net loss per share applicable to common stockholders for the second quarter of 2007 was $0.60, compared to $0.61 in the first quarter of 2007 and $1.11 in the second quarter of 2006. -- Cash and marketable securities decreased by $10.3 million during the second quarter. Changes included $16.0 million of operating losses, increases in prepaid expenses of $1.5 million for insurance, clinical trial and marketing expenses, and $0.2 million in fixed asset additions and other changes in working capital. These items were further offset by increases in accrued R&D expenses and accounts payable of $2.0 million, and $5.4 million of non-cash depreciation, amortization, and stock-based compensation expenses. -- The balance sheet at the end of the second quarter of 2007 reflected $119.7 million of unrestricted cash, cash equivalents and marketable securities, compared to $130.0 million as of March 31, 2007, and $31.9 million as of December 31, 2006.
FINANCIAL GUIDANCE
As previously discussed, full year 2007 financial results are expected to show total cash used in company operations to be approximately $80 million to $90 million. The total cash balance at December 31, 2007 is expected to be between $55 million and $65 million, and does not include any proceeds from collaborations or partnerships that the company may enter into in 2007. Vanda anticipates that its current funds will be sufficient to complete the work necessary to file an NDA for iloperidone by the end of 2007, to continue the pre-launch commercial activities for iloperidone, to expend funds on the extended-release injectable formulation of iloperidone, to initiate at least one additional VEC-162 Phase III trial for chronic sleep disorders in the second half of 2007, to conduct a VSF-173 Phase II trial for excessive sleepiness and to continue additional R&D activities into mid-2008.
Net loss for the year is expected to be between $110 million to $120 million, or approximately $4.18 to $4.56 per share. Non-cash charges for 2007, consisting primarily of stock-based compensation expense and depreciation and amortization, are expected to be approximately $20 million. Per share figures were computed on a weighted average basis of 26,321,527 shares of common stock outstanding at the end of the year.
CONFERENCE CALL
The company has scheduled a conference call for today, Thursday, August 2, 2007 at 10:30 AM ET. During the call, Mihael Polymeropoulos, M.D., President and CEO, and Steven Shallcross, Sr. Vice President and CFO, will discuss quarterly results and other corporate activities. Investors can call 1-866-362-4829 (domestic) and 1-617-597-5346 (international) prior to the 10:30 AM start time and ask for the Vanda Pharmaceuticals conference call hosted by Dr. Polymeropoulos. A replay of the call will be available Thursday, August 2, 2007, at 12:30 PM ET and will be accessible until Thursday, August 9, 2007, at 5:00 PM ET. The replay call-in number is 1-888-286-8010 for domestic callers and 1-617-801-6888 for international callers. The access number is 35380190.
The conference call will be broadcast simultaneously on the company’s Web site, http://www.vandapharma.com. Investors should click on the Investor Relations tab and are advised to go to the Web site at least 15 minutes early to register, download, and install any necessary software. The call will also be archived on the Vanda Web site for a period of 30 days, through September 1, 2007.
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. The company has three product candidates in clinical development. Vanda’s lead product candidate, iloperidone, is a compound for the treatment of schizophrenia and bipolar disorder and has recently completed its Phase III program in schizophrenia. Vanda’s second product candidate, VEC-162, is a compound for the treatment of sleep and mood disorders which is currently in Phase III for sleep disorders. Vanda’s third product candidate, VSF-173, is a compound for the treatment of excessive sleepiness that is currently in a Phase II trial. For more on Vanda Pharmaceuticals Inc., please visit http://www.vandapharma.com.
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding Vanda’s plans for its product candidates. Words such as, but not limited to, “look forward to,” “believe,” “expect,” “anticipate,” “estimate,” “intend,” “plan,” “targets,” “likely,” “will,” “would,” “should,” and “could,” and similar expressions or words identify forward-looking statements. Such 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 Vanda’s forward-looking statements include, among others, a failure of Vanda’s product candidates to be demonstrably safe and effective, a failure to obtain regulatory approval for the company’s products or to comply with ongoing regulatory requirements, a lack of acceptance of Vanda’s product candidates in the marketplace, a failure of the company to become or remain profitable, Vanda’s inability to obtain the capital necessary to fund its research and development activities, a loss of any of the company’s key scientists or management personnel, and other factors that are described in the “Risk Factors” section (Part II, Item 1A) of Vanda’s report on Form 10-Q for the quarter ended March 31, 2007 (File No. 000-51863). No forward-looking statements can be guaranteed and actual results may differ materially from such statements. The information in this release is provided only as of the date of this release, and Vanda undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.
VANDA PHARMACEUTICALS INC. (A Development Stage Enterprise) CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) Three Months Ended June 30, June 30, 2007 2006 Revenues from services $- $- Operating expenses: Research and development 10,193,825 19,099,850 General and administrative 7,449,375 2,980,642 Total operating expenses 17,643,200 22,080,492 Loss from operations (17,643,200) (22,080,492) Interest income 1,659,781 709,033 Interest expense - (1,625) Total other income, net 1,659,781 707,408 Loss before tax provision (15,983,419) (21,373,084) Tax provision 1,604 - Net loss applicable to common stockholders $(15,985,023) $(21,373,084) Basic and diluted net loss per share applicable to common stockholders $(0.60) $(1.11) Shares used in calculation of basic and diluted net loss per share applicable to common stockholders 26,567,160 19,183,660 Six Months Ended June 30, June 30, 2007 2006 Revenues from services $- $- Operating expenses: Research and development 20,785,884 34,588,404 General and administrative 13,682,924 5,905,590 Total operating expenses 34,468,808 40,493,994 Loss from operations (34,468,808) (40,493,994) Interest income 3,093,435 1,002,893 Interest expense - (4,433) Total other income, net 3,093,435 998,460 Loss before tax provision (31,375,373) (39,495,534) Tax provision 2,410 - Net loss applicable to common stockholders $(31,377,783) $(39,495,534) Basic and diluted net loss per share applicable to common stockholders $(1.21) $(4.11) Shares used in calculation of basic and diluted net loss per share applicable to common stockholders 25,978,437 9,616,347 VANDA PHARMACEUTICALS INC. (A Development Stage Enterprise) CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) June 30, 2007 December 31, 2006 ASSETS Current assets: Cash and cash equivalents $47,630,957 $30,928,895 Marketable securities 72,031,191 941,981 Prepaid expenses, deposits and other current assets 3,305,553 1,949,466 Total current assets 122,967,701 33,820,342 Property and equipment, net 1,770,566 1,859,704 Deposits 150,000 150,000 Restricted cash 430,230 430,230 Total assets $125,318,497 $36,260,276 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable $2,600,433 $2,783,249 Accrued expenses 6,290,164 6,322,808 Deferred grant revenue 141,229 - Total current liabilities 9,031,826 9,106,057 Long-term liabilities: Deferred rent 253,736 238,413 Deferred grant revenue - 129,950 Other long-term liabilities - 28,984 Total liabilities 9,285,562 9,503,404 Stockholders’ equity: Common stock 26,610 22,129 Additional paid-in capital 247,232,208 126,578,588 Accumulated other comprehensive loss (7,524) (3,269) Deficit accumulated during the development stage (131,218,359) (99,840,576) Total stockholders’ equity 116,032,935 26,756,872 Total liabilities and stockholders’ equity $125,318,497 $36,260,276 VANDA PHARMACEUTICALS INC. (A Development Stage Enterprise) CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) Six Months Ended June 30, June 30, 2007 2006 Cash flows from operating activities: Net loss $(31,377,783) (39,495,534) Adjustments to reconcile net income to net cash used in operating activities: Depreciation and amortization 293,660 247,860 Employee and non-employee stock-based compensation 9,323,664 3,017,878 Loss on disposal of assets - 29,528 Accretion of discount on investments (859,296) (188,447) Changes in assets and liabilities: Prepaid expenses and other current assets (1,354,085) 132,458 Deposits - 660,000 Accounts payable (183,682) 2,723,025 Accrued expenses (33,290) 9,135,082 Other liabilities (13,661) 142,711 Net cash used in operating activities (24,204,473) (23,595,439) Cash flows from investing activities: Purchases of property and equipment (202,683) (871,225) Purchases of marketable securities (93,239,541) (96,197,639) Proceeds from sales of marketable securities - 82,137,888 Maturities of marketable securities 23,025,000 10,670,000 Net cash used in investing activities (70,417,224) (4,260,976) Cash flows from financing activities: Principal payments on obligations under capital lease - (704) Principal payments on note payable - (92,888) Proceeds from exercise of stock options and warrants 79,587 48,885 Proceeds from issuance of common stock, net of issuance costs 111,254,850 53,329,951 Net cash provided by financing activities 111,334,437 53,285,244 Effect of foreign currency translation (10,678) (2,023) Net increase in cash and cash equivalents 16,702,062 25,426,806 Cash and cash equivalents, beginning of period 30,928,895 21,012,815 Cash and cash equivalents, end of period $47,630,957 $46,439,621
Vanda Pharmaceuticals Inc.
CONTACT: Steven A. Shallcross, Senior Vice President, Chief FinancialOfficer of Vanda Pharmaceuticals Inc., +1-240-599-4500,sshallcross@vandapharma.com
Web site: http://www.vandapharma.com//
