Full Press Release Details
Vanda Pharmaceuticals Reports First Quarter 2016 Financial Results
WASHINGTON May 4, 2016 Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA), today announced financial and operational results for the
first quarter ended March 31, 2016.
Vanda made significant progress in the first quarter of 2016, said Mihael H. Polymeropoulos, M.D.,
Vanda s President and CEO. We continued to grow our HETLIOZ and Fanapt franchises and we look forward to a number of important clinical development milestones in the coming months.
HETLIOZ (tasimelteon)
Fanapt (iloperidone)
Cash, cash equivalents and marketable securities (Cash) were $138.3 million as of March 31, 2016,
representing a decrease to Cash of $4.9 million in the first quarter of 2016.
Non-GAAP Financial Results
For the first quarter of 2016, Non-GAAP net loss was $7.1 million, or $0.17 per share, compared to a Non-GAAP net loss of $4.1 million, or $0.10 per share,
for the first quarter of 2015.
Vanda provides Non-GAAP financial information, which it believes can enhance an overall understanding of its financial
performance when considered together with GAAP figures. Refer to the sections of this press release entitled Non-GAAP Financial Information and Reconciliation of GAAP to Non-GAAP Financial Information.
2016 Financial Guidance
Vanda reiterates its prior 2016
financial guidance and expects to achieve the following financial objectives in 2016:
Vanda has scheduled a conference call for today, Wednesday, May 4, 2016, at 4:30 PM ET. During the call, Vanda s management will discuss the first
quarter 2016 financial results and other corporate activities. Investors can call 1-888-771-4371 (domestic) or 1-847-585-4405 (international) and use passcode 42335557. A replay of the call will be available on Wednesday, May 4, 2016, beginning
at 7:00 PM ET and will be accessible until Wednesday, May 11, 2016, 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 passcode number is 42335557.
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.
Non-GAAP Financial Information
Vanda believes that the
Non-GAAP financial information provided in this press release can assist investors in understanding and assessing the ongoing economics of Vanda s business and reflect how it manages the business internally and sets operational goals.
Vanda s Non-GAAP Selling, general and administrative expenses and Non-GAAP Research and development expenses exclude stock-based compensation. Vanda s Non-GAAP Net income (loss), Non-GAAP Net
income (loss) per share and Non-GAAP Operating expenses excluding Cost of goods sold exclude stock-based compensation and intangible asset amortization.
Vanda believes that excluding the impact of these items better reflects the recurring economic characteristics of
its business, as well as Vanda s use of financial resources and its long-term performance.
This press release includes a projection of 2016 Non-GAAP
Operating expenses, excluding Cost of goods sold, a forward-looking Non-GAAP financial measure under the heading 2016 Financial Guidance. This Non-GAAP financial measure is determined by excluding cost of goods sold, stock-based
compensation and intangible asset amortization. Vanda is unable to reconcile this Non-GAAP guidance to GAAP because it is difficult to predict the future impact of these adjustments.
These Non-GAAP financial measures, as presented, may not be comparable to similarly titled measures reported by other companies since not all companies may
calculate these measures in an identical manner and, therefore, they are not necessarily an accurate measure of comparison between companies.
presentation of these Non-GAAP financial measures is not intended to be considered in isolation or as a substitute for guidance prepared in accordance with GAAP. The principal limitation of these Non-GAAP financial measures is that they exclude
significant elements that are required by GAAP to be recorded in Vanda s financial statements. In addition, they are subject to inherent limitations as they reflect the exercise of judgments by management in determining these Non-GAAP financial
measures. In order to compensate for these limitations, Vanda presents its Non-GAAP financial guidance in connection with its GAAP guidance. Investors are encouraged to review the reconciliation of our Non-GAAP financial measures to their most
directly comparable GAAP financial measure.
About Vanda Pharmaceuticals Inc.
Vanda is a specialty pharmaceutical company focused on the development and commercialization of novel therapies to address high unmet medical needs and
improve the lives of patients. For more on Vanda Pharmaceuticals Inc., please visit www.vandapharma.com.
CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS
Various statements in this release, including, but not limited to, the guidance provided in the subheading to this release and under 2016 Financial
Guidance above, are forward-looking statements under the securities laws. 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 Vanda s forward-looking statements include, among others, Vanda s assumptions regarding its ability to continue to grow its business in the U.S., Vanda s
ability to successfully commercialize 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, 2015, which is on file with the SEC and available on the SEC s website at www.sec.gov. Additional
factors may be described in those sections of Vanda s quarterly report on Form 10-Q for the quarter ended March 31, 2016, to be filed with the SEC in the second quarter of 2016. In addition to the risks described above and
in Vanda s annual report on Form 10-K and quarterly reports 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.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)
| Three Months Ended | ||||||||
| (in thousands, except for share and per share amounts) | March 31 2016 | March 31 2015 | ||||||
| Revenues: | ||||||||
| HETLIOZ product sales, net | $ | 16,201 | $ | 7,460 | ||||
| Fanapt product sales, net | 17,061 | 14,690 | ||||||
| Total revenues | 33,262 | 22,150 | ||||||
| Operating expenses: | ||||||||
| Cost of goods sold | 5,956 | 5,015 | ||||||
| Research and development | 7,548 | 4,478 | ||||||
| Selling, general and administrative | 29,290 | 18,806 | ||||||
| Intangible asset amortization | 2,943 | 4,144 | ||||||
| Total operating expenses | 45,737 | 32,443 | ||||||
| Loss from operations | (12,475 | ) | (10,293 | ) | ||||
| Other income | 117 | 72 | ||||||
| Net loss | $ | (12,358 | ) | $ | (10,221 | ) | ||
| Net loss per share, basic and diluted | $ | (0.29 | ) | $ | (0.24 | ) | ||
| Weighted average shares outstanding, basic and diluted | 43,104,462 | 41,744,948 |
VANDA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited)
| ($ in thousands) | March 31 2016 | December 31 2015 | ||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 38,740 | $ | 50,843 | ||||
| Marketable securities | 99,590 | 92,337 | ||||||
| Accounts receivable, net | 16,679 | 16,331 | ||||||
| Inventory | 938 | 1,294 | ||||||
| Prepaid expenses and other current assets | 6,502 | 5,742 | ||||||
| Total current assets | 162,449 | 166,547 | ||||||
| Property and equipment, net | 4,351 | 4,570 | ||||||
| Intangible assets, net | 35,809 | 38,752 | ||||||
| Non-current inventory and other | 4,131 | 3,181 | ||||||
| Total assets | $ | 206,740 | $ | 213,050 | ||||
| LIABILITIES AND STOCKHOLDERS EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued liabilities | $ | 22,664 | $ | 15,767 | ||||
| Accrued government and other rebates | 32,376 | 35,550 | ||||||
| Total current liabilities | 55,040 | 51,317 | ||||||
| Milestone obligation under license agreement | 25,000 | 25,000 | ||||||
| Other non-current liabilities | 3,688 | 3,706 | ||||||
| Total liabilities | 83,728 | 80,023 | ||||||
| Stockholders equity: | ||||||||
| Common stock | 43 | 43 | ||||||
| Additional paid-in capital | 463,084 | 460,794 | ||||||
| Accumulated other comprehensive income | 92 | 39 | ||||||
| Accumulated deficit | (340,207 | ) | (327,849 | ) | ||||
| Total stockholders equity | 123,012 | 133,027 | ||||||
| Total liabilities and stockholders equity | $ | 206,740 | $ | 213,050 |
VANDA PHARMACEUTICALS INC.
Reconciliation of GAAP to Non-GAAP Financial Information (Unaudited)
| Three Months Ended | ||||||||
| (in thousands, except for share and per share amounts) | March 31 2016 | March 31 2015 | ||||||
| Net loss | $ | (12,358 | ) | $ | (10,221 | ) | ||
| Adjustments: | ||||||||
| Stock-based compensation | 2,266 | 1,945 | ||||||
| Intangible asset amortization | 2,943 | 4,144 | ||||||
| Non-GAAP Net loss | $ | (7,149 | ) | $ | (4,132 | ) | ||
| Non-GAAP Net loss per share, basic and diluted | $ | (0.17 | ) | $ | (0.10 | ) | ||
| Weighted average shares outstanding, basic and diluted | 43,104,462 | 41,744,948 | ||||||
| Operating expenses | $ | 45,737 | $ | 32,443 | ||||
| Adjustments: | ||||||||
| Cost of goods sold | (5,956 | ) | (5,015 | ) | ||||
| Stock-based compensation | (2,266 | ) | (1,945 | ) | ||||
| Intangible asset amortization | (2,943 | ) | (4,144 | ) | ||||
| Non-GAAP Operating expenses excluding Cost of goods sold | $ | 34,572 | $ | 21,339 | ||||
| Research and development | $ | 7,548 | $ | 4,478 | ||||
| Adjustment: | ||||||||
| Stock-based compensation | (524 | ) | (624 | ) | ||||
| Non-GAAP Research and development | $ | 7,024 | $ | 3,854 | ||||
| Selling, general and administrative | $ | 29,290 | $ | 18,806 | ||||
| Adjustment: | ||||||||
| Stock-based compensation | (1,742 | ) | (1,321 | ) | ||||
| Non-GAAP Selling, general and administrative | $ | 27,548 | $ | 17,485 |
Senior Vice President & Chief Financial Officer
Pharmaceuticals Inc.
SOURCE Vanda Pharmaceuticals