Full Press Release Details
Vanda Pharmaceuticals Reports Fourth Quarter 2018 and Full Year
2018 Financial Results
WASHINGTON February 13, 2019 Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq:
VNDA) today announced financial and operational results for the fourth quarter and full year ended December 31, 2018.
strong commercial performance and positive clinical results has set 2018 apart as a transformative year for Vanda, said Mihael H. Polymeropoulos, M.D., Vanda s President and CEO. The tradipitant clinical programs in gastroparesis
and atopic dermatitis have emerged as potentially significant drivers of future growth with the possibility of bringing new treatment options to millions of patients.
Key Financial Highlights:
Research and Development Highlights:
Tradipitant Clinical Development
HETLIOZ (tasimelteon)
Fanapt (iloperidone)
VTR-297 (histone deactetylase (HDAC) inhibitor)
Tradipitant Partial Clinical Hold and FDA Dispute
Non-GAAP Financial Results
Non-GAAP net income was $13.7 million for the fourth quarter of 2018, or $0.26 per share, compared to a Non-GAAP net income of $1.4 million, or $0.03 per share, for the fourth quarter of 2017. Vanda Non-GAAP net income was $38.4 million for the full year 2018, compared
to a Non- GAAP net loss of $3.4 million for the full year 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 for more detailed information regarding Non-GAAP financial information.
2019 Financial Guidance
Vanda expects to achieve the
following financial objectives in 2019:
| Full Year 2019 Financial Objectives | Full Year 2019 Guidance | |
| Combined net product sales from both HETLIOZ and Fanapt | $215 to $225 million | |
| HETLIOZ net product sales | $137 to $143 million | |
| Fanapt net product sales | $78 to $82 million | |
| Year-end 2019 Cash | Greater than $260 million |
has scheduled a conference call for today, Wednesday, February 13, 2019, at 4:30 PM ET. During the call, Vanda s management will discuss the fourth quarter and full year 2018 financial results and other corporate activities. Investors can call 1-866-688-9426 (domestic) or 1-409-216-0816
(international) and use passcode 1579398. A replay of the call will be available on Wednesday, February 13, 2019, beginning at 7:30 PM ET and will be accessible until Wednesday, February 20, 2019, at 7:30 PM ET. The replay call-in number is 1-855-859-2056 for domestic callers and
1-404-537-3406 for international callers. The passcode number is 1579398.
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.
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.
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 LOOKING STATEMENTS
Various statements in this release, including, but not limited to, the guidance provided under 2019 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 gastroparesis and/or the treatment of chronic pruritus in atopic dermatitis, the outcome of the lawsuit initiated by Vanda
against the FDA relating to tradipitant, the ability of HETLIOZ to provide significant benefit in the treatment of the symptoms of jet lag disorder, Vanda s ability to obtain marketing
approval for the use of HETLIOZ in the treatment of jet lag disorder, Vanda s ability to complete the clinical development and obtain regulatory approval of tasimelteon for the treatment
of sleep disorders in patients with SMS 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 fiscal quarter ended September 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 annual report on Form 10-K for the fiscal year ended December
31, 2018, to be filed with the SEC in the first quarter of 2019. 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 | Twelve Months Ended | |||||||||||||||
| December 31 2018 | December 31 2017 | December 31 2018 | December 31 2017 | |||||||||||||
| Revenues: | ||||||||||||||||
| HETLIOZ product sales, net | $ | 32,444 | $ | 25,010 | $ | 115,835 | $ | 89,978 | ||||||||
| Fanapt product sales, net | 20,597 | 19,266 | 77,283 | 75,105 | ||||||||||||
| Total revenues | 53,041 | 44,276 | 193,118 | 165,083 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Cost of goods sold excluding amortization | 5,667 | 4,791 | 20,508 | 17,848 | ||||||||||||
| Research and development | 12,922 | 10,154 | 43,594 | 38,547 | ||||||||||||
| Selling, general and administrative | 24,922 | 31,049 | 105,751 | 123,841 | ||||||||||||
| Intangible asset amortization | 380 | 432 | 1,527 | 1,750 | ||||||||||||
| Total operating expenses | 43,891 | 46,426 | 171,380 | 181,986 | ||||||||||||
| Income (loss) from operations | 9,150 | (2,150 | ) | 21,738 | (16,903 | ) | ||||||||||
| Other income | 1,168 | 399 | 3,608 | 1,472 | ||||||||||||
| Income (loss) before income taxes | 10,318 | (1,751 | ) | 25,346 | (15,431 | ) | ||||||||||
| Provision (benefit) for income taxes | (42 | ) | 87 | 138 | 136 | |||||||||||
| Net income (loss) | $ | 10,360 | $ | (1,838 | ) | $ | 25,208 | $ | (15,567 | ) | ||||||
| Net income (loss) per share, basic | $ | 0.20 | $ | (0.04 | ) | $ | 0.50 | $ | (0.35 | ) | ||||||
| Net income (loss) per share, diluted | $ | 0.19 | $ | (0.04 | ) | $ | 0.48 | $ | (0.35 | ) | ||||||
| Weighted average shares outstanding, basic | 52,457,275 | 44,930,832 | 50,859,947 | 44,735,146 | ||||||||||||
| Weighted average shares outstanding, diluted | 55,216,507 | 44,930,832 | 53,045,257 | 44,735,146 |
VANDA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
| December 31 2018 (1) | December 31 2017 (1) | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 61,005 | $ | 33,627 | ||||
| Marketable securities | 196,355 | 109,786 | ||||||
| Accounts receivable, net | 28,780 | 17,601 | ||||||
| Inventory | 994 | 840 | ||||||
| Prepaid expenses and other current assets | 11,998 | 8,003 | ||||||
| Total current assets | 299,132 | 169,857 | ||||||
| Property and equipment, net | 4,417 | 5,306 | ||||||
| Intangible assets, net | 24,542 | 26,069 | ||||||
| Non-current inventory and other | 4,039 | 4,193 | ||||||
| Total assets | $ | 332,130 | $ | 205,425 | ||||
| LIABILITIES AND STOCKHOLDERS EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued liabilities | $ | 21,584 | $ | 20,335 | ||||
| Product revenue allowances | 31,231 | 23,028 | ||||||
| Milestone obligations under license agreements | 200 | 27,000 | ||||||
| Total current liabilities | 53,015 | 70,363 | ||||||
| Other non-current liabilities | 3,693 | 3,675 | ||||||
| Total liabilities | 56,708 | 74,038 | ||||||
| Stockholders equity: | ||||||||
| Common stock | 52 | 45 | ||||||
| Additional paid-in capital | 611,587 | 492,802 | ||||||
| Accumulated other comprehensive income (loss) | 1 | (34 | ) | |||||
| Accumulated deficit | (336,218 | ) | (361,426 | ) | ||||
| Total stockholders equity | 275,422 | 131,387 | ||||||
| Total liabilities and stockholders equity | $ | 332,130 | $ | 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 | Twelve Months Ended | |||||||||||||||
| December 31 2018 | December 31 2017 | December 31 2018 | December 31 2017 | |||||||||||||
| Net income (loss) | $ | 10,360 | $ | (1,838 | ) | $ | 25,208 | $ | (15,567 | ) | ||||||
| Adjustments: | ||||||||||||||||
| Stock-based compensation | 2,922 | 2,782 | 11,666 | 10,465 | ||||||||||||
| Intangible asset amortization | 380 | 432 | 1,527 | 1,750 | ||||||||||||
| Non-GAAP Net income (loss) | $ | 13,662 | $ | 1,376 | $ | 38,401 | $ | (3,352 | ) | |||||||
| Non-GAAP Net income (loss) per share, basic | $ | 0.26 | $ | 0.03 | $ | 0.76 | $ | (0.07 | ) | |||||||
| Weighted average shares outstanding, basic | 52,457,275 | 44,930,832 | 50,859,947 | 44,735,146 | ||||||||||||
| Operating expenses | $ | 43,891 | $ | 46,426 | $ | 171,380 | $ | 181,986 | ||||||||
| Adjustments: | ||||||||||||||||
| Cost of goods sold excluding amortization | (5,667 | ) | (4,791 | ) | (20,508 | ) | (17,848 | ) | ||||||||
| Stock-based compensation | (2,922 | ) | (2,782 | ) | (11,666 | ) | (10,465 | ) | ||||||||
| Intangible asset amortization | (380 | ) | (432 | ) | (1,527 | ) | (1,750 | ) | ||||||||
| Non-GAAP Operating expenses excluding Cost of goods sold | $ | 34,922 | $ | 38,421 | $ | 137,679 | $ | 151,923 | ||||||||
| Research and development | $ | 12,922 | $ | 10,154 | $ | 43,594 | $ | 38,547 | ||||||||
| Adjustment: | ||||||||||||||||
| Stock-based compensation | (327 | ) | (194 | ) | (1,290 | ) | (1,152 | ) | ||||||||
| Non-GAAP Research and development | $ | 12,595 | $ | 9,960 | $ | 42,304 | $ | 37,395 | ||||||||
| Selling, general and administrative | $ | 24,922 | $ | 31,049 | $ | 105,751 | $ | 123,841 | ||||||||
| Adjustment: | ||||||||||||||||
| Stock-based compensation | (2,595 | ) | (2,588 | ) | (10,376 | ) | (9,313 | ) | ||||||||
| Non-GAAP Selling, general and administrative | $ | 22,327 | $ | 28,461 | $ | 95,375 | $ | 114,528 |
Executive Vice President & Chief Financial Officer
Vanda Pharmaceuticals Inc. (202) 734-3428
SOURCE Vanda Pharmaceuticals