Full Press Release Details
Vanda Pharmaceuticals Reports Second Quarter 2017 Financial Results
WASHINGTON August 2, 2017 Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA) today announced financial and operational results
for the second quarter ended June 30, 2017.
During the second quarter of 2017, we advanced our company growth strategy and delivered strong
operational and financial results, said Mihael H. Polymeropoulos, M.D., Vanda s President and CEO.
HETLIOZ (tasimelteon)
Fanapt (iloperidone)
Research and Development
Cash, cash equivalents and marketable securities (Cash) were $137.1 million as of June 30, 2017, representing a decrease to Cash of
$0.6 million during the second quarter of 2017.
Non-GAAP Financial Results
For the second quarter of 2017, Non-GAAP net income was $1.6 million, or $0.03 per share, compared to a Non-GAAP net income of $0.4 million, or $0.01 per share, for the second quarter of 2016.
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.
2017 Financial Guidance
Vanda reiterates its prior 2017
financial guidance and 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 (2) | |
| 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, August 2, 2017, at 4:30 PM ET. During the call, Vanda s management will discuss the
second quarter 2017 financial results and other corporate activities. Investors can call 1-888-771-4371 (domestic) or 1-847-585-4405 (international) and use passcode 45253483. A replay of the call will be available on Wednesday, August 2, 2017,
beginning at 7:00 PM ET and will be accessible until Wednesday, August 9, 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 45253483.
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
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 request to the European Medicines Agency s Committee for Medicinal Products for Human Use
to review the negative opinion recommending against the marketing authorization for oral Fanaptum 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, 2016 and
quarterly report on Form 10-Q for the fiscal quarter ended March 31, 2017, 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 quarterly report on Form 10-Q for the fiscal quarter ended June 30, 2017, to be filed with the SEC in the third 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 | Six Months Ended | |||||||||||||||
| June 30 | June 30 | June 30 | June 30 | |||||||||||||
| 2017 | 2016 | 2017 | 2016 | |||||||||||||
| Revenues: | ||||||||||||||||
| HETLIOZ product sales, net | $ | 22,507 | $ | 17,460 | $ | 42,689 | $ | 33,661 | ||||||||
| Fanapt product sales, net | 19,549 | 18,569 | 36,782 | 35,630 | ||||||||||||
| Total revenues | 42,056 | 36,029 | 79,471 | 69,291 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Cost of goods sold excluding amortization | 4,529 | 6,494 | 8,532 | 12,450 | ||||||||||||
| Research and development | 7,648 | 6,700 | 18,215 | 14,248 | ||||||||||||
| Selling, general and administrative | 31,371 | 24,682 | 61,668 | 53,972 | ||||||||||||
| Intangible asset amortization | 432 | 2,942 | 886 | 5,885 | ||||||||||||
| Total operating expenses | 43,980 | 40,818 | 89,301 | 86,555 | ||||||||||||
| Loss from operations | (1,924 | ) | (4,789 | ) | (9,830 | ) | (17,264 | ) | ||||||||
| Other income | 397 | 171 | 677 | 288 | ||||||||||||
| Loss before income taxes | (1,527 | ) | (4,618 | ) | (9,153 | ) | (16,976 | ) | ||||||||
| Provision for income taxes | 7 | 26 | ||||||||||||||
| Net loss | $ | (1,534 | ) | $ | (4,618 | ) | $ | (9,179 | ) | $ | (16,976 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.03 | ) | $ | (0.11 | ) | $ | (0.21 | ) | $ | (0.39 | ) | ||||
| Weighted average shares outstanding, basic and diluted | 44,718,597 | 43,202,751 | 44,559,368 | 43,153,598 |
VANDA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
| June 30 2017 | December 31 2016 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 14,232 | $ | 40,426 | ||||
| Marketable securities | 122,886 | 100,914 | ||||||
| Accounts receivable, net | 21,024 | 20,268 | ||||||
| Inventory | 742 | 779 | ||||||
| Prepaid expenses and other current assets | 15,725 | 11,788 | ||||||
| Total current assets | 174,609 | 174,175 | ||||||
| Property and equipment, net | 5,709 | 5,015 | ||||||
| Intangible assets, net | 26,933 | 27,819 | ||||||
| Non-current inventory and other | 3,420 | 3,365 | ||||||
| Total assets | $ | 210,671 | $ | 210,374 | ||||
| LIABILITIES AND STOCKHOLDERS EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued liabilities | $ | 19,126 | $ | 16,196 | ||||
| Accrued government and other rebates | 31,310 | 34,124 | ||||||
| Milestone obligation under license agreement | 25,000 | |||||||
| Total current liabilities | 75,436 | 50,320 | ||||||
| Milestone obligation under license agreement | 25,000 | |||||||
| Other non-current liabilities | 3,817 | 3,724 | ||||||
| Total liabilities | 79,253 | 79,044 | ||||||
| Stockholders equity: | ||||||||
| Common stock | 45 | 44 | ||||||
| Additional paid-in capital | 486,400 | 477,087 | ||||||
| Accumulated other comprehensive income | 11 | 58 | ||||||
| Accumulated deficit | (355,038 | ) | (345,859 | ) | ||||
| Total stockholders equity | 131,418 | 131,330 | ||||||
| Total liabilities and stockholders equity | $ | 210,671 | $ | 210,374 |
VANDA PHARMACEUTICALS INC.
Reconciliation of GAAP to Non-GAAP Financial Information
(in thousands, except for share and per share amounts)
| Three Months Ended | Six Months Ended | |||||||||||||||
| June 30 2017 | June 30 2016 | June 30 2017 | June 30 2016 | |||||||||||||
| Net loss | $ | (1,534 | ) | $ | (4,618 | ) | $ | (9,179 | ) | $ | (16,976 | ) | ||||
| Adjustments: | ||||||||||||||||
| Stock-based compensation | 2,656 | 2,074 | 4,912 | 4,340 | ||||||||||||
| Intangible asset amortization | 432 | 2,942 | 886 | 5,885 | ||||||||||||
| Non-GAAP Net income (loss) | $ | 1,554 | $ | 398 | $ | (3,381 | ) | $ | (6,751 | ) | ||||||
| Non-GAAP Net income (loss) per share, basic | $ | 0.03 | $ | 0.01 | $ | (0.08 | ) | $ | (0.16 | ) | ||||||
| Weighted average shares outstanding, basic | 44,718,597 | 43,202,751 | 44,559,368 | 43,153,598 | ||||||||||||
| Operating expenses | $ | 43,980 | $ | 40,818 | $ | 89,301 | $ | 86,555 | ||||||||
| Adjustments: | ||||||||||||||||
| Cost of goods sold excluding amortization | (4,529 | ) | (6,494 | ) | (8,532 | ) | (12,450 | ) | ||||||||
| Stock-based compensation | (2,656 | ) | (2,074 | ) | (4,912 | ) | (4,340 | ) | ||||||||
| Intangible asset amortization | (432 | ) | (2,942 | ) | (886 | ) | (5,885 | ) | ||||||||
| Non-GAAP Operating expenses excluding Cost of goods sold | $ | 36,363 | $ | 29,308 | $ | 74,971 | $ | 63,880 | ||||||||
| Research and development | $ | 7,648 | $ | 6,700 | $ | 18,215 | $ | 14,248 | ||||||||
| Adjustment: | ||||||||||||||||
| Stock-based compensation | (285 | ) | (489 | ) | (694 | ) | (1,013 | ) | ||||||||
| Non-GAAP Research and development | $ | 7,363 | $ | 6,211 | $ | 17,521 | $ | 13,235 | ||||||||
| Selling, general and administrative | $ | 31,371 | $ | 24,682 | $ | 61,668 | $ | 53,972 | ||||||||
| Adjustment: | ||||||||||||||||
| Stock-based compensation | (2,371 | ) | (1,585 | ) | (4,218 | ) | (3,327 | ) | ||||||||
| Non-GAAP Selling, general and administrative | $ | 29,000 | $ | 23,097 | $ | 57,450 | $ | 50,645 |
Executive Vice President & Chief Financial Officer
Vanda Pharmaceuticals Inc.
SOURCE Vanda Pharmaceuticals Inc.