Full Press Release Details
Vanda Pharmaceuticals Reports First Quarter 2014 Results
WASHINGTON May 8, 2014 Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA), a biopharmaceutical company focused on the development and
commercialization of products for the treatment of central nervous system disorders, today announced financial and operational results for the first quarter ended March 31, 2014.
FIRST QUARTER 2014 REPORTED RESULTS
Total revenues for the first quarter of 2014 were $9.1 million, compared to $8.1 million for the first quarter of 2013. First quarter 2014 revenues included
$1.7 million in Fanapt royalties received from Novartis as compared to royalties of $1.5 million for the first quarter of 2013. Licensing revenues recognized from the amortization of the
$200.0 million upfront payment received from Novartis for Fanapt U.S. and Canadian rights were $7.5 million for the first quarter 2014, compared to $6.6 million for the first quarter of 2013.
The higher amortization amount in the first quarter of 2014 resulted from a shortening of the expected patent life for Fanapt in the U.S.
Total operating expenses for the first quarter of 2014 were $35.7 million, compared to $12.6 million for the first quarter of 2013. Selling, general and
administrative expenses of $27.9 million for the first quarter of 2014 were $23.7 million higher than for the same period in 2013 and reflect the increased commercial activity in preparation for the launch of HETLIOZ in the U.S.
First quarter 2014 financial results include $10.0 million for milestone payments associated with the FDA approval of the HETLIOZ New Drug Application.
An $8.0 million milestone payment was made to Bristol-Myers Squibb, which payment is treated as an intangible asset and will be amortized over the expected patent life of HETLIOZ in the U.S. A $2.0 million regulatory consulting milestone
payment was expensed to Research & development in the first quarter of 2014.
Vanda recorded a net loss of $26.5 million for the first quarter of
2014, compared to a net loss of $4.5 million for the first quarter of 2013. Diluted net loss per share for the first quarter of 2014 was $0.79, compared to a diluted net loss per share of $0.16 for the same period in 2013.
Cash, cash equivalents and marketable securities (Cash) were $100.4 million as of March 31, 2014.
First Quarter 2014 Key Financial Figures(1) (2)
| Three Months Ended | ||||||||||||||||
| ($ in thousands, except per share amounts) | March 31 2014 | December 31 2013 | Change ($) | Change (%) | ||||||||||||
| Total revenues | $ | 9,143 | $ | 8,783 | $ | 360 | 4 | % | ||||||||
| Research & development expenses | 7,263 | 6,270 | 993 | 16 | % | |||||||||||
| Selling, general & administrative expenses | 27,893 | 9,927 | 17,966 | 181 | % | |||||||||||
| Non-cash stock-based compensation 3 | 1,393 | 1,407 | (14 | ) | (1 | %) | ||||||||||
| Net loss | (26,533 | ) | (7,747 | ) | (18,786 | ) | (242 | %) | ||||||||
| Diluted net loss per share | $ | (0.79 | ) | $ | (0.23 | ) | $ | (0.56 | ) | (243 | %) |
Select Cash Flow Data(1)(2)
| Three Months Ended | ||||||||
| ($ in thousands) | March 31 2014 | March 31 2013 | ||||||
| Net cash provided by (used in) | ||||||||
| Operating activities | $ | (23,904 | ) | $ | (9,125 | ) | ||
| Investing activities | 389 | 30,477 | ||||||
| Financing activities | 2,011 | (193 | ) |
Select Balance Sheet Data(1)
| ($ in thousands) | March 31 2014 | December 31 2013 | March 31 2013 | |||||||||
| Total cash and marketable securities | $ | 100,402 | $ | 130,350 | $ | 110,932 |
OPERATIONAL HIGHLIGHTS
On January 31, 2014,
Vanda announced that the FDA approved HETLIOZ 20mg capsules for the treatment of Non-24. HETLIOZ is the first medication approved by the FDA for the treatment of Non-24. Non-24 affects the majority of totally blind individuals and it is
estimated that approximately 80,000 Americans have the disorder.
On April 21, 2014, Vanda launched HETLIOZ in the U.S.
HETLIOZSolutions was launched to support and facilitate the treatment of blind individuals in the U.S. living with Non-24. HETLIOZSolutions provides patients with a host of resources including information about Non-24 and
HETLIOZ , insurance support, overview of financial assistance programs, and pharmacy access.
During the first quarter of 2014, the Non-24 Disease
Awareness campaign was expanded with radio and television advertisements broadcast nationwide. Our awareness campaign has resulted in over 7,000 responses by individuals who opted in to learn more about Non-24 and its treatment. The majority of
responders are likely patients and friends and family of blind individuals. We have begun identifying Patient Directed Physician (PDP) targets and, over the last few weeks, our field force has called upon approximately 500 PDPs, which we believe
will benefit patients as they seek appropriate treatment for their condition.
Vanda expects to file for European regulatory approval of HETLIOZ during 2014. This begins the effort to
expand the availability of HETLIOZ to markets outside of the U.S. HETLIOZ was previously granted orphan drug designation by the European Commission for the treatment of Non-24.
Vanda recorded first quarter 2014 revenues of $9.1 million including Fanapt royalties of $1.7
million. Fanapt prescriptions, as reported by IMS, were approximately 40,600 for the first quarter of 2014. This represents a 6% decrease versus fourth quarter 2013 prescriptions and a 5%
increase over first quarter 2013 Fanapt prescriptions.
2014 FINANCIAL GUIDANCE
Full HETLIOZ Prescribing Information can be found at: www.hetlioz.com.
Vanda has scheduled a conference
call for today, Thursday, May 8, 2014, at 10:00 AM ET. During the call, Vanda s management will discuss the first quarter 2014 financial results and other corporate activities. Investors can call 1-888-895-5271 (domestic) and
1-847-619-6547 (international) and use passcode 37132179. A replay of the call will be available beginning Thursday, May 8, 2014 at 12:30 PM ET and will be accessible until Thursday, May 15, 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 37132179.
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 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 tasimelteon in Europe 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 and
quarterly report on Form 10-Q for the quarter ended March 31, 2014, which are on file with the SEC and available on the SEC s website at www.sec.gov. 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
VANDA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)
| Three Months Ended | ||||||||
| ($ in thousands, except per share amounts) | March 31 2014 | March 31 2013 (1) | ||||||
| Revenues: | ||||||||
| Licensing agreement | $ | 7,452 | $ | 6,606 | ||||
| Royalty revenue | 1,691 | 1,462 | ||||||
| Total revenues | 9,143 | 8,068 | ||||||
| Operating expenses: | ||||||||
| Research and development | 7,263 | 8,111 | ||||||
| Selling, general and administrative | 27,893 | 4,153 | ||||||
| Intangible asset amortization | 565 | 369 | ||||||
| Total operating expenses | 35,721 | 12,633 | ||||||
| Loss from operations | (26,578 | ) | (4,565 | ) | ||||
| Other income | 45 | 46 | ||||||
| Loss before tax benefit | (26,533 | ) | (4,519 | ) | ||||
| Tax benefit | ||||||||
| Net loss | $ | (26,533 | ) | $ | (4,519 | ) | ||
| Net loss per share: | ||||||||
| Basic and diluted | $ | (0.79 | ) | $ | (0.16 | ) | ||
| Shares used in calculations of net loss per share: | ||||||||
| Basic and diluted | 33,678,706 | 28,345,555 |
VANDA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited)
| ($ in thousands) | March 31, 2014 | December 31, 2013 (1) | ||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 43,260 | $ | 64,764 | ||||
| Marketable securities | 57,142 | 65,586 | ||||||
| Accounts receivable | 1,691 | 2,031 | ||||||
| Inventory | 192 | |||||||
| Prepaid expenses and other current assets | 3,132 | 2,703 | ||||||
| Restricted cash | 100 | 530 | ||||||
| Total current assets | 105,517 | 135,614 | ||||||
| Property and equipment, net | 2,208 | 2,198 | ||||||
| Intangible asset, net | 12,472 | 5,037 | ||||||
| Restricted cash, non-current | 785 | 500 | ||||||
| Total assets | $ | 120,982 | $ | 143,349 | ||||
| LIABILITIES AND STOCKHOLDERS EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 953 | $ | 661 | ||||
| Accrued liabilities | 13,164 | 5,180 | ||||||
| Deferred rent | 228 | 221 | ||||||
| Deferred revenues | 31,059 | 26,789 | ||||||
| Total current liabilities | 45,404 | 32,851 | ||||||
| Deferred rent, non-current | 2,831 | 2,888 | ||||||
| Deferred revenues, non-current | 51,764 | 63,486 | ||||||
| Total liabilities | 99,999 | 99,225 | ||||||
| Stockholders equity: | ||||||||
| Common stock | 34 | 33 | ||||||
| Additional paid-in capital | 355,644 | 352,240 | ||||||
| Accumulated other comprehensive income | 8 | 21 | ||||||
| Accumulated deficit | (334,703 | ) | (308,170 | ) | ||||
| Total stockholders equity | 20,983 | 44,124 | ||||||
| Total liabilities and stockholders equity | $ | 120,982 | $ | 143,349 |
SOURCE Vanda Pharmaceuticals Inc.