Full Press Release Details
Vanda Pharmaceuticals Reports Fourth Quarter 2016 and Full Year 2016 Financial Results
WASHINGTON February 15, 2017 Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA), today announced financial and operational
results for the fourth quarter and full year ended December 31, 2016.
2016 was an exceptional year for Vanda as we continued to demonstrate
strong growth in our commercial business and secured long-term exclusivity for Fanapt, said Mihael H. Polymeropoulos, M.D., Vanda s President and CEO. In addition, our emerging pipeline with important 2017 milestones underscores
Vanda s commitment to bringing important new treatment options to patients and the creation of shareholder value.
HETLIOZ (tasimelteon)
Fanapt (iloperidone)
Cash, cash equivalents and marketable securities (Cash) were $141.3 million as of December 31, 2016, representing a
decrease to Cash of $1.8 million during 2016.
Research and Development Progress and Objectives
Non-GAAP Financial Results
For the fourth quarter of 2016, Non-GAAP net income was $3.6 million, compared to a
Non-GAAP net loss of $10.0 million for the fourth quarter of 2015. Vanda Non-GAAP net income was $1.5 million for the full year 2016, compared to a Non-GAAP net loss of $18.9 million for the full year 2015.
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 entitled Non-GAAP Financial Information and Reconciliation of GAAP to Non-GAAP Financial Information.
2017 Financial Guidance
Vanda expects to achieve the
following financial objectives in 2017:
| Financial Objectives | 2017 Guidance | |
| Combined net product sales from both HETLIOZ and Fanapt | $165 to $175 million | |
| HETLIOZ net product sales | $88 to $93 million | |
| Fanapt net product sales | $77 to $82 million | |
| Non-GAAP Operating expenses, excluding Cost of goods sold (1) | $162 to $172 million | |
| Intangible asset amortization | $1.7 million | |
| Stock-based compensation | $9 to $12 million | |
| Year-end 2017 Cash | $121 to $141 million |
Vanda has scheduled a conference call for today, Wednesday, February 15, 2017, at 4:30 PM ET. During the call, Vanda s management will discuss the
fourth quarter and full year 2016 financial results and other corporate activities. Investors can call 1-888-771-4371 (domestic)
or 1-847-585-4405 (international) and use passcode 44159815. A replay of the call will be available on Wednesday,
February 15, 2017, beginning at 7:00 PM ET and will be accessible until Wednesday, February 22, 2017, 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 44159815.
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 2017 Non-GAAP Operating expenses, excluding Cost of goods sold, a forward-looking Non-GAAP financial measure under the heading 2017 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.
The 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 global biopharmaceutical company focused on the development and commercialization of innovative 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
Various statements in this release, including, but not limited to, the guidance provided in the subheading to this release and
under 2017 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 and quarterly report on Form 10-Q for the quarter ended September 30, 2016, which are 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
annual report on Form 10-K for the fiscal year ended December 31, 2016, to be filed with the SEC in the first quarter of 2017. 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
(in thousands, except for share and per share amounts)
| Three Months Ended | Year Ended | |||||||||||||||
| December 31 | December 31 | December 31 | December 31 | |||||||||||||
| 2016 | 2015 | 2016 | 2015 | |||||||||||||
| Revenues: | ||||||||||||||||
| HETLIOZ product sales, net | $ | 19,295 | $ | 15,143 | $ | 71,671 | $ | 44,302 | ||||||||
| Fanapt product sales, net | 18,949 | 16,706 | 74,346 | 65,623 | ||||||||||||
| Total revenues | 38,244 | 31,849 | 146,017 | 109,925 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Cost of goods sold | 5,272 | 6,171 | 24,712 | 23,462 | ||||||||||||
| Research and development | 7,614 | 8,747 | 29,156 | 29,145 | ||||||||||||
| Selling, general and administrative | 23,907 | 28,881 | 99,787 | 84,531 | ||||||||||||
| Intangible asset amortization | 2,105 | 2,943 | 10,933 | 12,972 | ||||||||||||
| Total operating expenses | 38,898 | 46,742 | 164,588 | 150,110 | ||||||||||||
| Loss from operations | (654 | ) | (14,893 | ) | (18,571 | ) | (40,185 | ) | ||||||||
| Other income | 154 | 95 | 665 | 320 | ||||||||||||
| Loss before income taxes | (500 | ) | (14,798 | ) | (17,906 | ) | (39,865 | ) | ||||||||
| Provision for income taxes | 104 | 104 | ||||||||||||||
| Net loss | $ | (604 | ) | $ | (14,798 | ) | $ | (18,010 | ) | $ | (39,865 | ) | ||||
| Net loss per share: | ||||||||||||||||
| Basic | $ | (0.01 | ) | $ | (0.35 | ) | $ | (0.41 | ) | $ | (0.94 | ) | ||||
| Diluted | $ | (0.01 | ) | $ | (0.35 | ) | $ | (0.41 | ) | $ | (0.94 | ) | ||||
| Weighted average shares outstanding: | ||||||||||||||||
| Basic | 43,968,730 | 42,815,291 | 43,449,441 | 42,250,254 | ||||||||||||
| Diluted | 43,968,730 | 42,815,291 | 43,449,441 | 42,250,254 |
VANDA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
| December 31 | December 31 | |||||||
| 2016 | 2015 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 40,426 | $ | 50,843 | ||||
| Marketable securities | 100,914 | 92,337 | ||||||
| Accounts receivable, net | 20,268 | 16,331 | ||||||
| Inventory | 779 | 1,294 | ||||||
| Prepaid expenses and other current assets | 11,788 | 5,742 | ||||||
| Total current assets | 174,175 | 166,547 | ||||||
| Property and equipment, net | 5,015 | 4,570 | ||||||
| Intangible assets, net | 27,819 | 38,752 | ||||||
| Non-current inventory and other | 3,365 | 3,181 | ||||||
| Total assets | $ | 210,374 | $ | 213,050 | ||||
| LIABILITIES AND STOCKHOLDERS EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued liabilities | $ | 16,196 | $ | 15,767 | ||||
| Accrued government and other rebates | 34,124 | 35,550 | ||||||
| Total current liabilities | 50,320 | 51,317 | ||||||
| Milestone obligation under license agreement | 25,000 | 25,000 | ||||||
| Other non-current liabilities | 3,724 | 3,706 | ||||||
| Total liabilities | 79,044 | 80,023 | ||||||
| Stockholders equity: | ||||||||
| Common stock | 44 | 43 | ||||||
| Additional paid-in capital | 477,087 | 460,794 | ||||||
| Accumulated other comprehensive income | 58 | 39 | ||||||
| Accumulated deficit | (345,859 | ) | (327,849 | ) | ||||
| Total stockholders equity | 131,330 | 133,027 | ||||||
| Total liabilities and stockholders equity | $ | 210,374 | $ | 213,050 |
VANDA PHARMACEUTICALS INC.
Reconciliation of GAAP to Non-GAAP Financial Information
(in thousands, except for share and per share amounts)
| Three Months Ended | Year Ended | |||||||||||||||
| December 31 | December 31 | December 31 | December 31 | |||||||||||||
| 2016 | 2015 | 2016 | 2015 | |||||||||||||
| Net loss | $ | (604 | ) | $ | (14,798 | ) | $ | (18,010 | ) | $ | (39,865 | ) | ||||
| Adjustments: | ||||||||||||||||
| Stock-based compensation | 2,103 | 1,887 | 8,543 | 7,961 | ||||||||||||
| Intangible asset amortization | 2,105 | 2,943 | 10,933 | 12,972 | ||||||||||||
| Non-GAAP Net income (loss) | $ | 3,604 | $ | (9,968 | ) | $ | 1,466 | $ | (18,932 | ) | ||||||
| Non-GAAP Net income (loss) per share, basic | $ | 0.08 | $ | (0.23 | ) | $ | 0.03 | $ | (0.45 | ) | ||||||
| Weighted average shares outstanding, basic | 43,968,730 | 42,815,291 | 43,449,441 | 42,250,254 | ||||||||||||
| Operating expenses | $ | 38,898 | $ | 46,742 | $ | 164,588 | $ | 150,110 | ||||||||
| Adjustments: | ||||||||||||||||
| Cost of goods sold | (5,272 | ) | (6,171 | ) | (24,712 | ) | (23,462 | ) | ||||||||
| Stock-based compensation | (2,103 | ) | (1,887 | ) | (8,543 | ) | (7,961 | ) | ||||||||
| Intangible asset amortization | (2,105 | ) | (2,943 | ) | (10,933 | ) | (12,972 | ) | ||||||||
| Non-GAAP Operating expenses excluding Cost of goods sold | $ | 29,418 | $ | 35,741 | $ | 120,400 | $ | 105,715 | ||||||||
| Research and development | $ | 7,614 | $ | 8,747 | $ | 29,156 | $ | 29,145 | ||||||||
| Adjustment: | ||||||||||||||||
| Stock-based compensation | (535 | ) | (526 | ) | (2,087 | ) | (2,269 | ) | ||||||||
| Non-GAAP Research and development | $ | 7,079 | $ | 8,221 | $ | 27,069 | $ | 26,876 | ||||||||
| Selling, general and administrative | $ | 23,907 | $ | 28,881 | $ | 99,787 | $ | 84,531 | ||||||||
| Adjustment: | ||||||||||||||||
| Stock-based compensation | (1,568 | ) | (1,361 | ) | (6,456 | ) | (5,692 | ) | ||||||||
| Non-GAAP Selling, general and administrative | $ | 22,339 | $ | 27,520 | $ | 93,331 | $ | 78,839 |
Senior Vice President & Chief Financial Officer
Pharmaceuticals Inc.
SOURCE Vanda Pharmaceuticals