Full Press Release Details
Vanda Pharmaceuticals Reports Third Quarter 2016 Financial Results
WASHINGTON November 2, 2016 Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA), today announced financial and operational results
for the third quarter ended September 30, 2016.
This quarter marks a significant milestone for Vanda, having secured long-term exclusivity for
Fanapt and demonstrated our ability to grow our commercial assets and expand our pipeline of products, said Mihael H. Polymeropoulos, M.D., Vanda s President and CEO.
HETLIOZ (tasimelteon)
Fanapt (iloperidone)
Non-GAAP Financial Results
For the third quarter of
2016, Non-GAAP net income was $4.6 million, compared to a Non-GAAP net loss of $4.5 million, for the third 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:
| Financial Objectives | 2016 Guidance | |||
| Combined net product sales from both HETLIOZ and Fanapt | $143 to $153 million | |||
| HETLIOZ net product sales | $73 to $78 million | (2) | ||
| Fanapt net product sales | $70 to $75 million | |||
| Non-GAAP Operating expenses, excluding Cost of goods sold (1) | $125 to $135 million | (2) | ||
| Intangible asset amortization | $10.9 million | |||
| Stock-based compensation | $8 to $10 million | |||
| Year end 2016 Cash | $123 to $143 million | (3) |
Vanda has scheduled a conference call for today, Wednesday, November 2, 2016, at 4:30 PM ET. During the call, Vanda s management will discuss the
third 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 43560411. A replay of the call will be available on Wednesday, November 2,
2016, beginning at 7:00 PM ET and will be accessible until Wednesday, November 9, 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
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
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 and quarterly report on Form 10-Q for the quarter ended June 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 quarterly report on Form 10-Q for the quarter ended September 30, 2016, to be filed with the SEC in
the fourth 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 | Nine Months Ended | |||||||||||||||
| September 30, | September 30, | September 30, | September 30, | |||||||||||||
| ($ in thousands, except per share amounts) | 2016 | 2015 | 2016 | 2015 | ||||||||||||
| Revenues: | ||||||||||||||||
| HETLIOZ product sales, net | $ | 18,715 | $ | 11,682 | $ | 52,376 | $ | 29,159 | ||||||||
| Fanapt product sales, net | 19,767 | 16,662 | 55,397 | 48,917 | ||||||||||||
| Total revenues | 38,482 | 28,344 | 107,773 | 78,076 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Cost of goods sold | 6,990 | 6,510 | 19,440 | 17,291 | ||||||||||||
| Research and development | 7,294 | 9,974 | 21,542 | 20,398 | ||||||||||||
| Selling, general and administrative | 21,908 | 18,458 | 75,880 | 55,650 | ||||||||||||
| Intangible asset amortization | 2,943 | 2,943 | 8,828 | 10,029 | ||||||||||||
| Total operating expenses | 39,135 | 37,885 | 125,690 | 103,368 | ||||||||||||
| Loss from operations | (653 | ) | (9,541 | ) | (17,917 | ) | (25,292 | ) | ||||||||
| Other income | 223 | 80 | 511 | 225 | ||||||||||||
| Net loss | $ | (430 | ) | $ | (9,461 | ) | $ | (17,406 | ) | $ | (25,067 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.01 | ) | $ | (0.22 | ) | $ | (0.40 | ) | $ | (0.60 | ) | ||||
| Weighted average shares outstanding, basic and diluted | 43,515,404 | 42,435,405 | 43,275,074 | 42,059,839 |
VANDA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited)
| ($ in thousands) | September 30 2016 | December 31 2015 | ||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 32,765 | $ | 50,843 | ||||
| Marketable securities | 109,814 | 92,337 | ||||||
| Accounts receivable, net | 15,928 | 16,331 | ||||||
| Inventory | 865 | 1,294 | ||||||
| Prepaid expenses and other current assets | 11,036 | 5,742 | ||||||
| Total current assets | 170,408 | 166,547 | ||||||
| Property and equipment, net | 4,731 | 4,570 | ||||||
| Intangible assets, net | 29,924 | 38,752 | ||||||
| Non-current inventory and other | 3,380 | 3,181 | ||||||
| Total assets | $ | 208,443 | $ | 213,050 | ||||
| LIABILITIES AND STOCKHOLDERS EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued liabilities | $ | 17,572 | $ | 15,767 | ||||
| Accrued government and other rebates | 33,109 | 35,550 | ||||||
| Total current liabilities | 50,681 | 51,317 | ||||||
| Milestone obligation under license agreement | 25,000 | 25,000 | ||||||
| Other non-current liabilities | 3,597 | 3,706 | ||||||
| Total liabilities | 79,278 | 80,023 | ||||||
| Stockholders equity: | ||||||||
| Common stock | 44 | 43 | ||||||
| Additional paid-in capital | 474,234 | 460,794 | ||||||
| Accumulated other comprehensive income | 142 | 39 | ||||||
| Accumulated deficit | (345,255 | ) | (327,849 | ) | ||||
| Total stockholders equity | 129,165 | 133,027 | ||||||
| Total liabilities and stockholders equity | $ | 208,443 | $ | 213,050 |
VANDA PHARMACEUTICALS INC.
Reconciliation of GAAP to Non-GAAP Financial Information (Unaudited)
| Three Months Ended | Nine Months Ended | |||||||||||||||
| September 30, | September 30, | September 30, | September 30, | |||||||||||||
| (in thousands, except for share and per share amounts) | 2016 | 2015 | 2016 | 2015 | ||||||||||||
| Net loss | $ | (430 | ) | $ | (9,461 | ) | $ | (17,406 | ) | $ | (25,067 | ) | ||||
| Adjustments: | ||||||||||||||||
| Stock-based compensation | 2,100 | 2,061 | 6,440 | 6,074 | ||||||||||||
| Intangible asset amortization | 2,943 | 2,943 | 8,828 | 10,029 | ||||||||||||
| Non-GAAP Net income (loss) | $ | 4,613 | $ | (4,457 | ) | $ | (2,138 | ) | $ | (8,964 | ) | |||||
| Non-GAAP Net income (loss) per share, basic | $ | 0.11 | $ | (0.11 | ) | $ | (0.05 | ) | $ | (0.21 | ) | |||||
| Weighted average shares outstanding, basic | 43,515,404 | 42,435,405 | 43,275,074 | 42,059,839 | ||||||||||||
| Operating expenses | $ | 39,135 | $ | 37,885 | $ | 125,690 | $ | 103,368 | ||||||||
| Adjustments: | ||||||||||||||||
| Cost of goods sold | (6,990 | ) | (6,510 | ) | (19,440 | ) | (17,291 | ) | ||||||||
| Stock-based compensation | (2,100 | ) | (2,061 | ) | (6,440 | ) | (6,074 | ) | ||||||||
| Intangible asset amortization | (2,943 | ) | (2,943 | ) | (8,828 | ) | (10,029 | ) | ||||||||
| Non-GAAP Operating expenses excluding Cost of goods sold | $ | 27,102 | $ | 26,371 | $ | 90,982 | $ | 69,974 | ||||||||
| Research and development | $ | 7,294 | $ | 9,974 | $ | 21,542 | $ | 20,398 | ||||||||
| Adjustment: | ||||||||||||||||
| Stock-based compensation | (539 | ) | (516 | ) | (1,552 | ) | (1,743 | ) | ||||||||
| Non-GAAP Research and development | $ | 6,755 | $ | 9,458 | $ | 19,990 | $ | 18,655 | ||||||||
| Selling, general and administrative | $ | 21,908 | $ | 18,458 | $ | 75,880 | $ | 55,650 | ||||||||
| Adjustment: | ||||||||||||||||
| Stock-based compensation | (1,561 | ) | (1,545 | ) | (4,888 | ) | (4,331 | ) | ||||||||
| Non-GAAP Selling, general and administrative | $ | 20,347 | $ | 16,913 | $ | 70,992 | $ | 51,319 |
Senior Vice President & Chief Financial Officer
Pharmaceuticals Inc.
SOURCE Vanda Pharmaceuticals