Full Press Release Details
Vanda Pharmaceuticals Reports Third Quarter 2014 Financial Results
WASHINGTON October 27, 2014 Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA), today announced financial and operational
results for the third quarter ended September 30, 2014.
Our innovative approach to the commercialization of HETLIOZ for Non-24 has yielded impressive third quarter revenue. We are developing a robust commercial engine that has just begun to access the Non-24 market in the U.S. by creating awareness leading to
diagnosis and treatment. said Mihael Polymeropoulos M.D., Vanda s President and CEO. The Named Patient Program launch in the EU and Canada under the HetliozAccess initiative furthers our commitment to patients with Non-24
Our commercial and clinical pipeline is also advancing with the recent launch of Fanapt in Israel, the planned launch of Fanapt in Mexico, the HETLIOZ European
Marketing Authorization Application, and development activities in pediatric Non-24, Smith-Magenis Syndrome, and chronic pruritus, added Dr. Polymeropoulos.
HETLIOZ (tasimelteon)
Fanapt (iloperidone)
Clinical pipeline advances
THIRD QUARTER 2014 REPORTED RESULTS
revenues for the third quarter of 2014 were $14.8 million, compared to $10.9 million for the second quarter of 2014 and $8.7 million for the third quarter of 2013. Net product revenues related to U.S. sales of HETLIOZ in the third quarter of 2014 were $5.2 million as compared to $1.6 million in the second quarter of 2014.
Total operating expenses for the third quarter of 2014 were $16.2 million, compared to $32.5 million for the second quarter of 2014 and $14.1 million for the
third quarter of 2013. Vanda recorded a net loss of $1.4 million for the third quarter of 2014, compared to a net loss of $21.6 million for the second quarter of 2014 and $5.4 million for the third quarter of 2013. Diluted net loss per share for the
third quarter of 2014 was $0.04, compared to a net loss per share of $0.64 during the second quarter of 2014 and $0.17 for the third quarter of 2013.
Cash, cash equivalents and marketable securities were $56.1 million as of September 30, 2014.
REVISED 2014 FINANCIAL GUIDANCE
Full HETLIOZ Prescribing Information can be
found at: www.hetlioz.com.
Vanda has scheduled a conference call for today, Monday, October 27, 2014, at 10:00 AM ET. During the call, Vanda s management will discuss the third
quarter 2014 financial results and other corporate activities. Investors can call 1-800-708-4540 (domestic) and 1-847-619-6397 (international) and use passcode 38296232. A replay of the call will be available beginning Monday, October 27, 2014
at 12:30 PM ET and will be accessible until Monday, November 3, 2014, at 11:59 PM ET. The replay call-in number is 1-888-843-7419 for domestic callers and 1-630-652-3042 for international callers. The access number is 38296232.
The conference call will be broadcast simultaneously on Vanda s website, www.vandapharma.com.
Investors should click on the Investor Relations tab and are advised to go to the website at least 15 minutes early to register, download, and install any necessary software or presentations. The call will also be archived on Vanda s website
for a period of 30 days.
ABOUT VANDA PHARMACEUTICALS INC.:
Vanda Pharmaceuticals Inc. is a biopharmaceutical company focused on the development and commercialization of products for the treatment of central nervous
system disorders. For more on Vanda, please visit www.vandapharma.com.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
Various statements in this release, including, but not limited to, the guidance provided under REVISED 2014 FINANCIAL GUIDANCE above, are
forward-looking statements under the securities laws. Words such as, but not limited to, believe, expect, anticipate, estimate, intend, plan, project,
target, goal, likely, will, would, and could, or the negative of these terms 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. Important factors that could cause actual results to differ materially from those reflected in the company s forward-looking
statements include, among others: Vanda s ability to successfully commercialize HETLIOZ for the treatment of Non-24 in the U.S., uncertainty as to the market awareness of Non-24 and the
market acceptance of HETLIOZ , Vanda s dependence on third-party manufacturers to manufacture HETLIOZ in sufficient quantities
and quality, Vanda s limited sales and marketing infrastructure, the regulatory status of HETLIOZ in Europe, Vanda s and its partners ability to successfully commercialize
Fanapt in Israel and Mexico, the results of Vanda s clinical development activities with respect to Non-24 in children, SMS and chronic pruritus and other factors that are described in
the Risk Factors and Management s Discussion and Analysis of Financial Condition and Results of Operations sections of Vanda s annual report on Form 10-K for the fiscal year ended December 31, 2013 which is on
file with the SEC and available on the SEC s website at www.sec.gov and Vanda s quarterly report on Form 10-Q for the quarter ended September 30, 2014 to be filed with the SEC. In addition to the risks described above and in
Vanda s annual report on Form 10-K and quarterly reports on Form 10-Q, current reports on Form 8-K and other filings with the SEC, 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.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)
| Three Months Ended | Nine Months Ended | |||||||||||||||
| September 30, | September 30, | September 30, | September 30, | |||||||||||||
| ($ in thousands, except per share amounts) | 2014 | 2013 (1) | 2014 | 2013 (1) | ||||||||||||
| Revenues: | ||||||||||||||||
| HETLIOZ product revenue, net (2) | $ | 5,222 | $ | $ | 6,781 | $ | ||||||||||
| Fanapt product revenue, net (ex-U.S.) | 107 | 107 | ||||||||||||||
| Fanapt royalty revenue | 1,689 | 1,956 | 4,919 | 5,059 | ||||||||||||
| Fanapt licensing agreement (3) | 7,764 | 6,753 | 22,981 | 20,037 | ||||||||||||
| Total revenues | 14,782 | 8,709 | 34,788 | 25,096 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Cost of sales (4) | 703 | 901 | ||||||||||||||
| Research and development | 3,701 | 8,022 | 14,479 | 22,233 | ||||||||||||
| Selling, general and administrative | 11,290 | 5,741 | 67,321 | 15,154 | ||||||||||||
| Intangible asset amortization | 536 | 377 | 1,718 | 1,118 | ||||||||||||
| Total operating expenses | 16,230 | 14,140 | 84,419 | 38,505 | ||||||||||||
| Loss from operations | (1,448 | ) | (5,431 | ) | (49,631 | ) | (13,409 | ) | ||||||||
| Other income | 22 | 25 | 98 | 101 | ||||||||||||
| Net loss | $ | (1,426 | ) | $ | (5,406 | ) | $ | (49,533 | ) | $ | (13,308 | ) | ||||
| Net loss per share: | ||||||||||||||||
| Basic and diluted | $ | (0.04 | ) | $ | (0.17 | ) | $ | (1.46 | ) | $ | (0.45 | ) | ||||
| Shares used in calculations of net loss per share: | ||||||||||||||||
| Basic and diluted | 33,886,845 | 31,332,993 | 33,814,154 | 29,363,162 |
VANDA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited)
| September 30, | December 31, | |||||||
| ($ in thousands) | 2014 | 2013 (1) | ||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 15,308 | $ | 64,764 | ||||
| Marketable securities | 40,781 | 65,586 | ||||||
| Accounts receivable | 3,696 | 2,031 | ||||||
| Inventory | 1,268 | |||||||
| Prepaid expenses and other current assets | 3,785 | 2,703 | ||||||
| Restricted cash | 530 | |||||||
| Total current assets | 64,838 | 135,614 | ||||||
| Property and equipment, net | 2,233 | 2,198 | ||||||
| Intangible asset, net | 11,319 | 5,037 | ||||||
| Restricted cash, non-current | 785 | 500 | ||||||
| Total assets | $ | 79,175 | $ | 143,349 | ||||
| LIABILITIES AND STOCKHOLDERS EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 547 | $ | 661 | ||||
| Accrued liabilities | 6,825 | 5,180 | ||||||
| Deferred rent | 241 | 221 | ||||||
| Deferred revenues | 31,232 | 26,789 | ||||||
| Total current liabilities | 38,845 | 32,851 | ||||||
| Deferred rent, non-current | 2,919 | 2,888 | ||||||
| Deferred revenues, non-current | 36,235 | 63,486 | ||||||
| Other liabilities | 113 | |||||||
| Total liabilities | 78,112 | 99,225 | ||||||
| Stockholders equity: | ||||||||
| Common stock | 34 | 33 | ||||||
| Additional paid-in capital | 358,728 | 352,240 | ||||||
| Accumulated other comprehensive income | 4 | 21 | ||||||
| Accumulated deficit | (357,703 | ) | (308,170 | ) | ||||
| Total stockholders equity | 1,063 | 44,124 | ||||||
| Total liabilities and stockholders equity | $ | 79,175 | $ | 143,349 |
SOURCE Vanda Pharmaceuticals Inc.