Full Press Release Details
Vanda Pharmaceuticals Reports Third Quarter 2017 Financial Results
WASHINGTON November 7,
2017 Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA) today announced financial and operational results for the third quarter ended September 30, 2017.
During the third quarter of 2017, Vanda demonstrated the importance of the diverse set of ongoing initiatives to advance our growth strategy, said
Mihael H. Polymeropoulos, M.D., Vanda s President and CEO. The tradipitant results in atopic dermatitis, early trends from the HETLIOZ to psychiatrists initiative and the resolution of the HETLIOZ pricing negotiation in Germany, all
represent significant potential drivers of growth.
HETLIOZ (tasimelteon)
Fanapt (iloperidone)
Research and Development
VTR-297 (histone deactetylase (HDAC) inhibitor)
Cash, cash equivalents and marketable securities (Cash) were $139.9 million as of
September 30, 2017, representing an increase to Cash of $2.8 million during the third quarter of 2017.
Non-GAAP Financial Results
For the third quarter of 2017, Non-GAAP net loss was $1.3 million, or $0.03 per share, compared to a Non-GAAP net income of $4.6 million, or $0.11 per share, for the third 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 is updating its 2017 financial guidance and expects to achieve the following financial objectives in 2017:
| Fourth Quarter 2017 Financial Objectives | Fourth Quarter 2017 Guidance | |||
| Combined net product sales from both HETLIOZ and Fanapt | $42 to $48 million | |||
| HETLIOZ net product sales | $24 to $27 million | |||
| Fanapt net product sales | $18 to $21 million | |||
| Full Year 2017 Financial Objectives | Revised Full Year 2017 Guidance | Prior Full Year 2017 Guidance | ||
| Combined net product sales from both HETLIOZ and Fanapt | $163 to $169 million | $165 to $175 million | ||
| HETLIOZ net product sales | $89 to $92 million | $88 to $93 million | ||
| Fanapt net product sales | $74 to $77 million | $77 to $82 million | ||
| Non-GAAP Operating expenses, excluding Cost of goods sold (1) | $150 to $157 million | $162 to $172 million | ||
| Intangible asset amortization | $1.7 million | $1.7 million | ||
| Stock-based compensation | $9 to $12 million | $9 to $12 million | ||
| Year-end 2017 Cash | $131 to $141 million | $121 to $141 million |
Vanda has scheduled a conference call
for today, Tuesday, November 7, 2017, at 4:30 PM ET. During the call, Vanda s management will discuss the third 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 45886211. A replay of the call will be available on Tuesday, November 7, 2017, beginning at 7:00 PM ET and will be accessible until Tuesday, November 14, 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 45886211.
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
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.
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
CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS
Various statements in this release, including, but not limited to, the guidance provided 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. through the HETLIOZ to Psychiatrists Initiative, among other means, Vanda s ability to complete the clinical development and obtain regulatory approval of tradipitant for the treatment of atopic dermatitis,
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, 2016 and quarterly report on Form 10-Q for the fiscal quarter ended June 30, 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 September 30, 2017, to be filed with
the SEC in the fourth 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 | Nine Months Ended | |||||||||||||||
| September 30 2017 | September 30 2016 | September 30 2017 | September 30 2016 | |||||||||||||
| Revenues: | ||||||||||||||||
| HETLIOZ product sales, net | $ | 22,279 | $ | 18,715 | $ | 64,968 | $ | 52,376 | ||||||||
| Fanapt product sales, net | 19,057 | 19,767 | 55,839 | 55,397 | ||||||||||||
| Total revenues | 41,336 | 38,482 | 120,807 | 107,773 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Cost of goods sold excluding amortization | 4,525 | 6,990 | 13,057 | 19,440 | ||||||||||||
| Research and development | 10,178 | 7,294 | 28,393 | 21,542 | ||||||||||||
| Selling, general and administrative | 31,124 | 21,908 | 92,792 | 75,880 | ||||||||||||
| Intangible asset amortization | 432 | 2,943 | 1,318 | 8,828 | ||||||||||||
| Total operating expenses | 46,259 | 39,135 | 135,560 | 125,690 | ||||||||||||
| Loss from operations | (4,923 | ) | (653 | ) | (14,753 | ) | (17,917 | ) | ||||||||
| Other income | 396 | 223 | 1,073 | 511 | ||||||||||||
| Loss before income taxes | (4,527 | ) | (430 | ) | (13,680 | ) | (17,406 | ) | ||||||||
| Provision for income taxes | 23 | 49 | ||||||||||||||
| Net loss | $ | (4,550 | ) | $ | (430 | ) | $ | (13,729 | ) | $ | (17,406 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.10 | ) | $ | (0.01 | ) | $ | (0.31 | ) | $ | (0.40 | ) | ||||
| Weighted average shares outstanding, basic and diluted | 44,885,287 | 43,515,404 | 44,669,201 | 43,275,074 |
VANDA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
| September 30 2017 | December 31 2016 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 22,586 | $ | 40,426 | ||||
| Marketable securities | 117,295 | 100,914 | ||||||
| Accounts receivable, net | 18,179 | 20,268 | ||||||
| Inventory | 921 | 779 | ||||||
| Prepaid expenses and other current assets | 10,738 | 11,788 | ||||||
| Total current assets | 169,719 | 174,175 | ||||||
| Property and equipment, net | 5,448 | 5,015 | ||||||
| Intangible assets, net | 26,501 | 27,819 | ||||||
| Non-current inventory and other | 4,038 | 3,365 | ||||||
| Total assets | $ | 205,706 | $ | 210,374 | ||||
| LIABILITIES AND STOCKHOLDERS EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued liabilities | $ | 18,921 | $ | 16,196 | ||||
| Accrued government and other rebates | 25,615 | 34,124 | ||||||
| Milestone obligations under license agreements | 27,000 | |||||||
| Total current liabilities | 71,536 | 50,320 | ||||||
| Milestone obligation under license agreement | 25,000 | |||||||
| Other non-current liabilities | 3,701 | 3,724 | ||||||
| Total liabilities | 75,237 | 79,044 | ||||||
| Stockholders equity: Common stock | 45 | 44 | ||||||
| Additional paid-in capital | 489,939 | 477,087 | ||||||
| Accumulated other comprehensive income | 73 | 58 | ||||||
| Accumulated deficit | (359,588 | ) | (345,859 | ) | ||||
| Total stockholders equity | 130,469 | 131,330 | ||||||
| Total liabilities and stockholders equity | $ | 205,706 | $ | 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 | Nine Months Ended | |||||||||||||||
| September 30 2017 | September 30 2016 | September 30 2017 | September 30 2016 | |||||||||||||
| Net loss | $ | (4,550 | ) | $ | (430 | ) | $ | (13,729 | ) | $ | (17,406 | ) | ||||
| Adjustments: | ||||||||||||||||
| Stock-based compensation | 2,771 | 2,100 | 7,683 | 6,440 | ||||||||||||
| Intangible asset amortization | 432 | 2,943 | 1,318 | 8,828 | ||||||||||||
| Non-GAAP Net income (loss) | $ | (1,347 | ) | $ | 4,613 | $ | (4,728 | ) | $ | (2,138 | ) | |||||
| Non-GAAP Net income (loss) per share, basic | $ | (0.03 | ) | $ | 0.11 | $ | (0.11 | ) | $ | (0.05 | ) | |||||
| Weighted average shares outstanding, basic | 44,885,287 | 43,515,404 | 44,669,201 | 43,275,074 | ||||||||||||
| Operating expenses | $ | 46,259 | $ | 39,135 | $ | 135,560 | $ | 125,690 | ||||||||
| Adjustments: | ||||||||||||||||
| Cost of goods sold excluding amortization | (4,525 | ) | (6,990 | ) | (13,057 | ) | (19,440 | ) | ||||||||
| Stock-based compensation | (2,771 | ) | (2,100 | ) | (7,683 | ) | (6,440 | ) | ||||||||
| Intangible asset amortization | (432 | ) | (2,943 | ) | (1,318 | ) | (8,828 | ) | ||||||||
| Non-GAAP Operating expenses excluding Cost of goods sold | $ | 38,531 | $ | 27,102 | $ | 113,502 | $ | 90,982 | ||||||||
| Research and development | $ | 10,178 | $ | 7,294 | $ | 28,393 | $ | 21,542 | ||||||||
| Adjustment: | ||||||||||||||||
| Stock-based compensation | (264 | ) | (539 | ) | (958 | ) | (1,552 | ) | ||||||||
| Non-GAAP Research and development | $ | 9,914 | $ | 6,755 | $ | 27,435 | $ | 19,990 | ||||||||
| Selling, general and administrative | $ | 31,124 | $ | 21,908 | $ | 92,792 | $ | 75,880 | ||||||||
| Adjustment: | ||||||||||||||||
| Stock-based compensation | (2,507 | ) | (1,561 | ) | (6,725 | ) | (4,888 | ) | ||||||||
| Non-GAAP Selling, general and administrative | $ | 28,617 | $ | 20,347 | $ | 86,067 | $ | 70,992 |
Executive Vice President & Chief Financial Officer
Vanda Pharmaceuticals Inc.
SOURCE Vanda Pharmaceuticals Inc.