Full Press Release Details
Vanda Pharmaceuticals Reports Third Quarter 2018 Financial Results
WASHINGTON November 7, 2018 Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced financial
and operational results for the third quarter ended September 30, 2018.
HETLIOZ (tasimelteon)
Fanapt (iloperidone)
Research and Development
HETLIOZ (tasimelteon)
Fanapt (iloperidone)
VTR-297 (histone deacetylase (HDAC) inhibitor)
Cash, cash equivalents and marketable securities (Cash) were
$240.6 million as of September 30, 2018. During the third quarter of 2018, Cash increased by $9.4 million.
Non-GAAP Financial Results
For the third quarter of 2018, Non-GAAP net
income was $10.4 million, compared to Non-GAAP net loss of $1.3 million for the third quarter of 2017.
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.
2018 Financial Guidance
Vanda reiterates its prior 2018 net product sales guidance and provides an update to Non-GAAP Operating Expenses,
Intangible Asset Amortization and Year-End 2018 Cash guidance and expects to achieve the following financial objectives in 2018:
| Full Year 2018 Financial Objectives | Full Year 2018 Guidance | |
| Combined net product sales from both HETLIOZ and Fanapt | $180 to $200 million | |
| HETLIOZ net product sales | $108 to $118 million | |
| Fanapt net product sales | $72 to $82 million | |
| Non-GAAP Operating expenses, excluding Cost of goods sold | $140 to $150 million as compared to prior guidance of $153 to $163 million | |
| Intangible asset amortization | $1.5 million as compared to prior guidance of $1.7 million | |
| Stock-based compensation | $11 to $15 million | |
| Year-end 2018 Cash | $240 to $250 million as compared to prior guidance of $225 to $235 million |
has scheduled a conference call for today, Wednesday, November 7, 2018, at 4:30 PM ET. During the call, Vanda s management will discuss the third quarter 2018 financial results and other corporate activities. Investors can call 1-888-771-4371 (domestic) or
(international) and use passcode 47697858. A replay of the call will be available on Wednesday, November 7, 2018, beginning at 7:00 PM ET and will be accessible until Wednesday,
November 14, 2018, 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 47697858.
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 2018 Non-GAAP Operating expenses, excluding Cost of goods sold, a forward-looking Non-GAAP financial measure under the heading 2018 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 2018 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 complete the
clinical development and obtain regulatory approval of tradipitant for the treatment of atopic dermatitis and the treatment of gastroparesis, 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, 2017 and quarterly report on Form 10-Q for the quarter
ended June 30, 2018, 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, 2018, to be filed with the SEC in the fourth quarter of 2018. 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 2018 | September 30 2017 | September 30 2018 | September 30 2017 | |||||||||||||
| Revenues: | ||||||||||||||||
| HETLIOZ product sales, net | $ | 29,923 | $ | 22,279 | $ | 83,391 | $ | 64,968 | ||||||||
| Fanapt product sales, net | 19,212 | 19,057 | 56,686 | 55,839 | ||||||||||||
| Total revenues | 49,135 | 41,336 | 140,077 | 120,807 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Cost of goods sold excluding amortization | 5,068 | 4,525 | 14,841 | 13,057 | ||||||||||||
| Research and development | 11,390 | 10,178 | 30,672 | 28,393 | ||||||||||||
| Selling, general and administrative | 26,047 | 31,124 | 80,829 | 92,792 | ||||||||||||
| Intangible asset amortization | 397 | 432 | 1,147 | 1,318 | ||||||||||||
| Total operating expenses | 42,902 | 46,259 | 127,489 | 135,560 | ||||||||||||
| Income (loss) from operations | 6,233 | (4,923 | ) | 12,588 | (14,753 | ) | ||||||||||
| Other income | 1,030 | 396 | 2,440 | 1,073 | ||||||||||||
| Income (loss) before income taxes | 7,263 | (4,527 | ) | 15,028 | (13,680 | ) | ||||||||||
| Provision for income taxes | 92 | 23 | 180 | 49 | ||||||||||||
| Net income (loss) | $ | 7,171 | $ | (4,550 | ) | $ | 14,848 | $ | (13,729 | ) | ||||||
| Net income (loss) per share, basic | $ | 0.14 | $ | (0.10 | ) | $ | 0.30 | $ | (0.31 | ) | ||||||
| Net income (loss) per share, diluted | $ | 0.13 | $ | (0.10 | ) | $ | 0.28 | $ | (0.31 | ) | ||||||
| Weighted average shares outstanding, basic | 52,389,012 | 44,885,287 | 50,321,640 | 44,669,201 | ||||||||||||
| Weighted average shares outstanding, diluted | 54,709,749 | 44,885,287 | 52,315,642 | 44,669,201 |
VANDA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
| September 30 2018 (1) | December 31 2017 (1) | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 60,778 | $ | 33,627 | ||||
| Marketable securities | 179,801 | 109,786 | ||||||
| Accounts receivable, net | 25,259 | 17,601 | ||||||
| Inventory | 887 | 840 | ||||||
| Prepaid expenses and other current assets | 12,082 | 8,003 | ||||||
| Total current assets | 278,807 | 169,857 | ||||||
| Property and equipment, net | 4,579 | 5,306 | ||||||
| Intangible assets, net | 24,922 | 26,069 | ||||||
| Non-current inventory and other | 3,629 | 4,193 | ||||||
| Total assets | $ | 311,937 | $ | 205,425 | ||||
| LIABILITIES AND STOCKHOLDERS EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued liabilities | $ | 19,046 | $ | 20,335 | ||||
| Product revenue allowances | 27,196 | 23,028 | ||||||
| Milestone obligations under license agreements | 27,000 | |||||||
| Total current liabilities | 46,242 | 70,363 | ||||||
| Other non-current liabilities | 4,278 | 3,675 | ||||||
| Total liabilities | 50,520 | 74,038 | ||||||
| Stockholders equity: | ||||||||
| Common stock | 52 | 45 | ||||||
| Additional paid-in capital | 607,873 | 492,802 | ||||||
| Accumulated other comprehensive income (loss) | 70 | (34 | ) | |||||
| Accumulated deficit | (346,578 | ) | (361,426 | ) | ||||
| Total stockholders equity | 261,417 | 131,387 | ||||||
| Total liabilities and stockholders equity | $ | 311,937 | $ | 205,425 |
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 2018 | September 30 2017 | September 30 2018 | September 30 2017 | |||||||||||||
| Net income (loss) | $ | 7,171 | $ | (4,550 | ) | $ | 14,848 | $ | (13,729 | ) | ||||||
| Adjustments: | ||||||||||||||||
| Stock-based compensation | 2,872 | 2,771 | 8,744 | 7,683 | ||||||||||||
| Intangible asset amortization | 397 | 432 | 1,147 | 1,318 | ||||||||||||
| Non-GAAP Net income (loss) | $ | 10,440 | $ | (1,347 | ) | $ | 24,739 | $ | (4,728 | ) | ||||||
| Non-GAAP Net income (loss) per share, basic | $ | 0.20 | $ | (0.03 | ) | $ | 0.49 | $ | (0.11 | ) | ||||||
| Weighted average shares outstanding, basic | 52,389,012 | 44,885,287 | 50,321,640 | 44,669,201 | ||||||||||||
| Operating expenses | $ | 42,902 | $ | 46,259 | $ | 127,489 | $ | 135,560 | ||||||||
| Adjustments: | ||||||||||||||||
| Cost of goods sold excluding amortization | (5,068 | ) | (4,525 | ) | (14,841 | ) | (13,057 | ) | ||||||||
| Stock-based compensation | (2,872 | ) | (2,771 | ) | (8,744 | ) | (7,683 | ) | ||||||||
| Intangible asset amortization | (397 | ) | (432 | ) | (1,147 | ) | (1,318 | ) | ||||||||
| Non-GAAP Operating expenses excluding Cost of goods sold | $ | 34,565 | $ | 38,531 | $ | 102,757 | $ | 113,502 | ||||||||
| Research and development | $ | 11,390 | $ | 10,178 | $ | 30,672 | $ | 28,393 | ||||||||
| Adjustment: | ||||||||||||||||
| Stock-based compensation | (326 | ) | (264 | ) | (963 | ) | (958 | ) | ||||||||
| Non-GAAP Research and development | $ | 11,064 | $ | 9,914 | $ | 29,709 | $ | 27,435 | ||||||||
| Selling, general and administrative | $ | 26,047 | $ | 31,124 | $ | 80,829 | $ | 92,792 | ||||||||
| Adjustment: | ||||||||||||||||
| Stock-based compensation | (2,546 | ) | (2,507 | ) | (7,781 | ) | (6,725 | ) | ||||||||
| Non-GAAP Selling, general and administrative | $ | 23,501 | $ | 28,617 | $ | 73,048 | $ | 86,067 |
Executive Vice President & Chief Financial Officer
Vanda Pharmaceuticals Inc.
SOURCE Vanda Pharmaceuticals Inc.