Full Press Release Details
Vanda Pharmaceuticals Reports Second Quarter 2014 Results
WASHINGTON August 7, 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 second quarter ended June 30, 2014.
We are encouraged by the early positive reception of HETLIOZ by patients, physicians and payors. We look forward to more patients benefiting from
HETLIOZ in the coming months and years, said Mihael Polymeropoulos MD, President and CEO of Vanda Pharmaceuticals.
SECOND QUARTER 2014 REPORTED RESULTS
Total revenues for the second quarter of 2014 were $10.9 million, compared to $9.1 million for the first quarter of 2014 and $8.3 million for the second
quarter of 2013. Net product revenues related to U.S. sales of HETLIOZ in the second quarter of 2014 were $1.6 million.
Total operating expenses for the second quarter of 2014 were $32.5 million, compared to $35.7 million for the first quarter of 2014 and $11.7 million for the
second quarter of 2013. Vanda recorded a net loss of $21.6 million for the second quarter of 2014, compared to a net loss of $26.5 million for the first quarter of 2014 and $3.4 million for the second quarter of 2013.
Cash, cash equivalents and marketable securities (Cash) were $63.6 million as of June 30, 2014.
Year to Date June 30, 2014 Key Financial Figures(1)
| Six Months Ended | ||||||||||||||||
| ($ in thousands, except per share amounts) | June 30, 2014 | June 30, 2013 | Change ($) | Change (%) | ||||||||||||
| Total revenues | $ | 20,005 | $ | 16,387 | $ | 3,618 | 22 | % | ||||||||
| Research & development expenses | 10,777 | 14,211 | (3,434 | ) | (24 | %) | ||||||||||
| Selling, general & administrative expenses | 56,032 | 9,413 | 46,619 | 495 | % | |||||||||||
| Non-cash stock-based compensation (3) | 2,836 | 2,432 | 404 | 17 | % | |||||||||||
| Net loss | (48,108 | ) | (7,902 | ) | (40,206 | ) | (509 | %) | ||||||||
| Diluted net loss per share | $ | (1.42 | ) | $ | (0.28 | ) | $ | (1.14 | ) | (407 | %) |
Second Quarter 2014 Key Financial Figures(1) (2)
| Three Months Ended | ||||||||||||||||
| ($ in thousands, except per share amounts) | June 30, 2014 | March 31, 2014 | Change ($) | Change (%) | ||||||||||||
| Total revenues | $ | 10,862 | $ | 9,143 | $ | 1,719 | 19 | % | ||||||||
| Research & development expenses | 3,514 | 7,263 | (3,749 | ) | (52 | %) | ||||||||||
| Selling, general & administrative expenses | 28,139 | 27,893 | 246 | 1 | % | |||||||||||
| Non-cash stock-based compensation (3) | 1,443 | 1,393 | 50 | 4 | % | |||||||||||
| Net loss | (21,575 | ) | (26,533 | ) | 4,958 | 19 | % | |||||||||
| Diluted net loss per share | $ | (0.64 | ) | $ | (0.79 | ) | $ | 0.15 | 19 | % |
Select Cash Flow Data(1)(2)
| Six Months Ended | ||||||||
| ($ in thousands) | June 30, 2014 | June 30, 2013 | ||||||
| Net cash provided by (used in) | ||||||||
| Operating activities | $ | (60,569 | ) | $ | (17,168 | ) | ||
| Investing activities | 10,756 | 31,428 | ||||||
| Financing activities | 2,043 | 601 |
Select Balance Sheet Data(1)
| ($ in thousands) | June 30, 2014 | December 31 2013 | June 30, 2013 | |||||||||
| Total Cash (4) | $ | 63,585 | $ | 130,350 | $ | 103,633 |
OPERATIONAL HIGHLIGHTS
As of August 6, 2014, over 420 new patient prescriptions have been written for HETLIOZ in the
U.S. This represents growth of approximately 90% in new prescriptions since the Company s June 4, 2014 commercial update. HETLIOZ was launched in the U.S. in April 2014 for the
treatment of Non-24, a disorder which affects the majority of totally blind individuals. It is estimated that approximately 80,000 Americans have the disorder.
On July 22, 2014, a new method of use patent was issued by the USPTO for HETLIOZ in the
treatment of Non-24 (patent number 8,785,492). The 492 patent is expected to expire in 2033, potentially further extending the exclusivity protection of HETLIOZ . In the U.S., HETLIOZ is also covered by a composition of matter patent (patent number 5,856,529), which including a Hatch-Waxman 5-year extension is currently expected to expire in 2022. Both patents, 529 and
492, are now listed in the FDA s Orange Book.
In June 2014, the EMA accepted for evaluation Vanda s Marketing Authorization Application
for oral HETLIOZ capsules for the treatment of Non-24. HETLIOZ was previously granted orphan drug designation by the European
Commission for the treatment of Non-24.
Vanda has initiated development activities for the use of
HETLIOZ in the pediatric population with Non-24, as well as in patients with Smith-Magenis syndrome.
The VLY-686, NK1 antagonist, Phase 2 study in chronic pruritus is ongoing and results are expected in mid-2015.
2014 FINANCIAL GUIDANCE
Total 2014 operating
expenses are expected to be between $110.0 and $120.0 million. This includes intangible asset amortization expense of $2.3 million and $6.0 to $8.0 million of non-cash stock based compensation.
Full HETLIOZ Prescribing Information can be found at: www.hetlioz.com.
Vanda has scheduled a
conference call for today, Thursday, August 7, 2014, at 10:00 AM ET. During the call, Vanda s management will discuss the second 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 37729521. A replay of the call will be available beginning Thursday, August 7, 2014 at 12:30 PM ET and will be accessible until Thursday, August 14, 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 37729521.
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 HETLIOZ 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 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 June 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
VANDA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)
| Three Months Ended | Six Months Ended | |||||||||||||||
| ($ in thousands, except per share amounts) | June 30, 2014 | June 30, 2013 (1) | June 30, 2014 | June 30, 2013 (1) | ||||||||||||
| Revenues: | ||||||||||||||||
| HETLIOZ product revenue (2) | $ | 1,559 | $ | $ | 1,559 | $ | ||||||||||
| Fanapt royalty revenue | 1,539 | 1,641 | 3,230 | 3,103 | ||||||||||||
| Fanapt licensing agreement (3) | 7,764 | 6,678 | 15,216 | 13,284 | ||||||||||||
| Total revenues | 10,862 | 8,319 | 20,005 | 16,387 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Cost of sales | 198 | 198 | ||||||||||||||
| Research and development | 3,514 | 6,100 | 10,777 | 14,211 | ||||||||||||
| Selling, general and administrative | 28,139 | 5,260 | 56,032 | 9,413 | ||||||||||||
| Intangible asset amortization | 617 | 372 | 1,182 | 741 | ||||||||||||
| Total operating expenses | 32,468 | 11,732 | 68,189 | 24,365 | ||||||||||||
| Loss from operations | (21,606 | ) | (3,413 | ) | (48,184 | ) | (7,978 | ) | ||||||||
| Other income | 31 | 30 | 76 | 76 | ||||||||||||
| Loss before tax benefit | (21,575 | ) | (3,383 | ) | (48,108 | ) | (7,902 | ) | ||||||||
| Tax benefit | ||||||||||||||||
| Net loss | $ | (21,575 | ) | $ | (3,383 | ) | $ | (48,108 | ) | $ | (7,902 | ) | ||||
| Net loss per share: | ||||||||||||||||
| Basic and diluted | $ | (0.64 | ) | $ | (0.12 | ) | $ | (1.42 | ) | $ | (0.28 | ) | ||||
| Shares used in calculations of net loss per share: | ||||||||||||||||
| Basic and diluted | 33,874,625 | 28,377,254 | 33,777,207 | 28,361,340 |
VANDA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited)
| ($ in thousands) | June 30, 2014 | December 31, 2013 (1) | ||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 16,994 | $ | 64,764 | ||||
| Marketable securities | 46,591 | 65,586 | ||||||
| Accounts receivable | 2,376 | 2,031 | ||||||
| Inventory | 1,093 | |||||||
| Prepaid expenses and other current assets | 4,166 | 2,703 | ||||||
| Restricted cash | 530 | |||||||
| Total current assets | 71,220 | 135,614 | ||||||
| Property and equipment, net | 2,312 | 2,198 | ||||||
| Intangible asset, net | 11,855 | 5,037 | ||||||
| Restricted cash, non-current | 785 | 500 | ||||||
| Total assets | $ | 86,172 | $ | 143,349 | ||||
| LIABILITIES AND STOCKHOLDERS EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 248 | $ | 661 | ||||
| Accrued liabilities | 6,753 | 5,180 | ||||||
| Deferred rent | 234 | 221 | ||||||
| Deferred revenues | 31,059 | 26,789 | ||||||
| Total current liabilities | 38,294 | 32,851 | ||||||
| Deferred rent, non-current | 2,853 | 2,888 | ||||||
| Deferred revenues, non-current | 44,000 | 63,486 | ||||||
| Other liabilities | 140 | |||||||
| Total liabilities | 85,287 | 99,225 | ||||||
| Stockholders equity: | ||||||||
| Common stock | 34 | 33 | ||||||
| Additional paid-in capital | 357,119 | 352,240 | ||||||
| Accumulated other comprehensive income | 10 | 21 | ||||||
| Accumulated deficit | (356,278 | ) | (308,170 | ) | ||||
| Total stockholders equity | 885 | 44,124 | ||||||
| Total liabilities and stockholders equity | $ | 86,172 | $ | 143,349 |
SOURCE Vanda Pharmaceuticals Inc.