Full Press Release Details
Vanda Pharmaceuticals Reports Fourth Quarter 2014 and Full Year 2014 Financial Results
WASHINGTON February 19, 2015 Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ:
VNDA), today announced financial and operational results for the fourth quarter and full year ended December 31, 2014.
transformational year for Vanda with the HETLIOZ launch in the U.S. for the treatment of Non-24-Hour Sleep-Wake Disorder. We are impressed with the continued growth of HETLIOZ and are fortunate to be able to offer this important treatment option for
patients said Mihael H. Polymeropoulos M.D., Vanda s President and CEO. The return of the U.S. and Canadian commercial rights to Fanapt brings an immediately accretive product to Vanda further strengthening our U.S. commercial
HETLIOZ (tasimelteon)
Fanapt (iloperidone)
VLY-686 (tradipitant)
Financial Results for the Fourth Quarter and Full Year 2014
Vanda total revenues for the fourth quarter of 2014 were $15.4 million, compared to $8.8 million for the fourth quarter of 2013. Vanda total revenues for the
full year 2014 were $50.2 million, compared to $33.9 million for 2013.
Selling, general and administrative expenses were $17.3 million in the fourth
quarter of 2014, compared to $9.9 million in the fourth quarter of 2013. Selling, general and administrative expenses were $84.6 million in the full year 2014, compared to $25.1 million in 2013. The increases in selling, general and administrative
expenses in fourth quarter and full year 2014 were the result of the U.S. commercial launch support for HETLIOZ .
Research and development expenses were $4.8 million in the fourth quarter of 2014, compared to $6.3 million in the fourth quarter of 2013. Research and
development expenses were $19.2 million in the full year 2014, compared to $28.5 million in 2013.
Vanda recorded a $77.6 million gain related to the
Novartis arbitration settlement in the fourth quarter of 2014.
Vanda net income was $69.7 million for the fourth quarter of 2014, compared to a net loss
of $7.7 million for the fourth quarter of 2013. Diluted net income per share for the fourth quarter of 2014 was $1.77, compared to a net loss per share of $0.23 for the fourth quarter of 2013. Vanda net income was $20.2 million for the full year
2014, compared to a net loss of $21.1 million for 2013. Diluted net income per share for the full year 2014 was $0.55, compared to a net loss per share of $0.69 for 2013.
In October 2014, Vanda completed a public common stock offering that resulted in $62.3 million in net proceeds. In December 2014, Vanda sold $25.0 million of
common stock to Novartis as part of the arbitration settlement. Cash, cash equivalents and marketable securities were $129.8 million as of December 31, 2014.
Non-GAAP Financial Results
Vanda Non-GAAP Total revenues
for the fourth quarter of 2014 were $7.6 million, compared to $2.0 million for the fourth quarter of 2013. Vanda Non-GAAP Total revenues for the full year 2014 were $19.4 million, compared to $7.1 million for 2013.
Vanda Non-GAAP Net loss was $13.5 million for the fourth quarter of 2014, compared to a net loss of $12.7 million for the fourth quarter of 2013. Non-GAAP
Diluted net loss per share for the fourth quarter of 2014 was $0.36, compared to a net loss per share of $0.38 for the fourth quarter of 2013. Vanda Non-GAAP net loss was $80.0 million for the full year 2014, compared to a net loss of $40.9 million
for 2013. Non-GAAP Diluted net loss per share for the full year 2014 was $2.30, compared to a net loss per share of $1.35 for 2013.
Vanda provides Non-GAAP financial information, which it believe can enhance an overall understanding of its
financial performance when considered together with GAAP figures. Refer to the sections of this press entitled Non-GAAP Financial Information and Reconciliation of GAAP to Non-GAAP Financial Information.
2015 Financial Guidance
Vanda expects to achieve the
following financial objectives in 2015:
for reporting periods beginning in 2015, Vanda will no longer record Fanapt licensing agreement revenues and will no longer report the number of HETLIOZ prescriptions written, dispensed or patients on therapy.
Full HETLIOZ Prescribing Information can be found at: www.hetlioz.com.
Full Fanapt Prescribing Information, including Boxed Warnings and Important Safety Information can be found at: www.fanapt.com.
Vanda has scheduled a conference call
for today, Thursday, February 19, 2015, at 10:00 AM ET. During the call, Vanda s management will discuss the fourth quarter and full year 2014 financial results and other corporate activities. Investors can call 1-800-708-4540 (domestic)
or 1-847-619-6397 (international) and use passcode 38933858. A replay of the call will be available beginning Thursday, February 19, 2015 at 12:30 PM ET and will be accessible until Thursday, February 26, 2015, 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 38933858.
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 release can assist investors in understanding and assessing the ongoing
economics of the Company s business and reflect how it manages the business internally and sets operational goals. Vanda s Non-
GAAP revenues excludes the Fanapt licensing agreement revenue. The Company s Non-GAAP G&A expenses and
Non-GAAP R&D expenses exclude stock based compensation. Non-GAAP net income (loss) and Non-GAAP Diluted net income (loss) per share excludes the Fanapt
licensing agreement revenue, stock based compensation, intangible asset amortization and gain on arbitration settlement.
Vanda believes that excluding
the impact of these items better reflects the recurring economic characteristics of its business and the Company s use of financial resources and the Company s long-term performance.
This press release includes Non-GAAP Operating expenses, a forward-looking Non-GAAP financial measures under the heading 2015 Financial Guidance .
This Non-GAAP financial measures was determined by excluding cost of sales, stock based compensation and intangibile asset amortization. We are unable to reconcile this Non-GAAP guidance to GAAP because it is difficult to predict the future impact
of these adjustment.
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 Pharmaceuticals Inc. is a biopharmaceutical company focused on the development and commercialization of products for the
treatment of central nervous system disorders. For more on Vanda, please visit www.vandapharma.com.
Forward-Looking Statements
Various statements in this release, including, but not limited to, the guidance provided in the heading of this press release and under 2015 Financial
Guidance above, are forward-looking statements under the securities laws. Words such as, but not limited to, believe, expect, anticipate, estimate, intend,
plan, project, target, goal, likely, will, would, and could, or the negative of these terms and similar expressions or words, identify forward-looking
statements. 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
the company s forward-looking statements include, among others: Vanda s ability to successfully commercialize HETLIOZ for the treatment of Non-24 in the U.S., uncertainty as to the
market awareness of Non-24 and the market acceptance of HETLIOZ , Vanda s dependence on third-party manufacturers to manufacture
HETLIOZ in sufficient quantities and quality, Vanda s limited sales and marketing infrastructure, the regulatory status of
HETLIOZ in Europe, Vanda s and
its partners ability to successfully commercialize Fanapt in the U.S., Israel and Mexico, the results of Vanda s clinical
development activities with respect to Non-24 in children, SMS and chronic pruritus; delays in the completion of Vanda s or its partners clinical trials; a failure of Vanda s products to be demonstrably safe and effective;
Vanda s expectations regarding trends with respect to its revenues, costs, expenses and liabilities; Vanda s failure to identify or obtain rights to new products; a loss of any of Vanda s key scientists or management personnel;
limitations on Vanda s ability to utilize some or all of its prior net operating losses and orphan drug and research and development credits; the costs and effects of potential litigation; losses incurred from product liability claims made
against Vanda 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, 2013 which is on file with the SEC and available on the SEC s website at www.sec.gov and Vanda s annual report on Form 10-K for the year ended December 31, 2014 to be filed with the SEC. In
addition to the risks described above and in Vanda s annual report on Form 10-K and quarterly reports on Form 10-Q, current reports on Form 8-K and other filings with the SEC, 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
| Three Months Ended | Twelve Months Ended | |||||||||||||||
| ($ in thousands, except per share amounts) | December 31, 2014 | December 31, 2013 (1) | December 31, 2014 | December 31, 2013 (1) | ||||||||||||
| Revenues: | ||||||||||||||||
| HETLIOZ product revenue, net | $ | 6,021 | $ | $ | 12,802 | $ | ||||||||||
| Fanapt product revenue, net | 107 | |||||||||||||||
| Fanapt royalty revenue | 1,584 | 2,031 | 6,502 | 7,090 | ||||||||||||
| Fanapt licensing agreement | 7,765 | 6,752 | 30,746 | 26,789 | ||||||||||||
| Total revenues | 15,370 | 8,783 | 50,157 | 33,879 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Cost of sales | 682 | 1,583 | ||||||||||||||
| Research and development | 4,752 | 6,270 | 19,230 | 28,502 | ||||||||||||
| Selling, general and administrative | 17,323 | 9,927 | 84,644 | 25,082 | ||||||||||||
| Intangible asset amortization | 536 | 377 | 2,254 | 1,495 | ||||||||||||
| Gain on arbitration settlement | (77,616 | ) | (77,616 | ) | ||||||||||||
| Total operating expenses | (54,323 | ) | 16,574 | 30,095 | 55,079 | |||||||||||
| Income (loss) from operations | 69,693 | (7,791 | ) | 20,062 | (21,200 | ) | ||||||||||
| Other income | 26 | 44 | 124 | 145 | ||||||||||||
| Net income (loss) | $ | 69,719 | $ | (7,747 | ) | $ | 20,186 | $ | (21,055 | ) | ||||||
| Net income (loss) per share: | ||||||||||||||||
| Basic | $ | 1.85 | $ | (0.23 | ) | $ | 0.58 | $ | (0.69 | ) | ||||||
| Diluted | $ | 1.77 | $ | (0.23 | ) | $ | 0.55 | $ | (0.69 | ) | ||||||
| Weighted average shares outstanding: | ||||||||||||||||
| Basic | 37,622,884 | 33,283,705 | 34,774,163 | 30,351,353 | ||||||||||||
| Diluted | 39,421,014 | 33,283,705 | 36,686,723 | 30,351,353 |
VANDA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
| ($ in thousands) | December 31, 2014 | December 31, 2013 (1) | ||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 60,901 | $ | 64,764 | ||||
| Marketable securities | 68,921 | 65,586 | ||||||
| Accounts receivable | 3,654 | 2,031 | ||||||
| Inventory | 5,170 | |||||||
| Prepaid expenses and other current assets | 3,084 | 2,703 | ||||||
| Restricted cash | 530 | |||||||
| Total current assets | 141,730 | 135,614 | ||||||
| Property and equipment, net | 2,437 | 2,198 | ||||||
| Intangible assets, net | 26,724 | 5,037 | ||||||
| Restricted cash, non-current | 785 | 500 | ||||||
| Other assets, non-current | 28 | |||||||
| Total assets | $ | 171,704 | $ | 143,349 | ||||
| LIABILITIES AND STOCKHOLDERS EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 835 | $ | 661 | ||||
| Accrued liabilities | 6,502 | 5,180 | ||||||
| Deferred rent | 247 | 221 | ||||||
| Deferred revenues | 174 | 26,789 | ||||||
| Other liabilities | 28 | |||||||
| Total current liabilities | 7,786 | 32,851 | ||||||
| Deferred rent, non-current | 3,101 | 2,888 | ||||||
| Deferred revenues, non-current | 63,486 | |||||||
| Total liabilities | 10,887 | 99,225 | ||||||
| Stockholders equity: | ||||||||
| Common stock | 41 | 33 | ||||||
| Additional paid-in capital | 448,744 | 352,240 | ||||||
| Accumulated other comprehensive income | 16 | 21 | ||||||
| Accumulated deficit | (287,984 | ) | (308,170 | ) | ||||
| Total stockholders equity | 160,817 | 44,124 | ||||||
| Total liabilities and stockholders equity | $ | 171,704 | $ | 143,349 |
VANDA PHARMACEUTICALS INC.
Reconciliation of GAAP to Non-GAAP Financial Information
| Three Months Ended | Twelve Months Ended | |||||||||||||||
| ($ in thousands, except per share amounts) | December 31, 2014 | December 31, 2013 (1) | December 31, 2014 | December 31, 2013 (1) | ||||||||||||
| Net income (loss) | $ | 69,719 | $ | (7,747 | ) | $ | 20,186 | $ | (21,055 | ) | ||||||
| Adjustments: | ||||||||||||||||
| Fanapt licensing agreement | (7,765 | ) | (6,752 | ) | (30,746 | ) | (26,789 | ) | ||||||||
| Stock based compensation | 1,631 | 1,409 | 5,878 | 5,404 | ||||||||||||
| Intangible asset amortization | 536 | 377 | 2,254 | 1,495 | ||||||||||||
| Gain on arbitration settlement | (77,616 | ) | (77,616 | ) | ||||||||||||
| Non-GAAP Net loss | $ | (13,495 | ) | $ | (12,713 | ) | $ | (80,044 | ) | $ | (40,945 | ) | ||||
| Non-GAAP Net loss per share: | ||||||||||||||||
| Basic & diluted | $ | (0.36 | ) | $ | (0.38 | ) | $ | (2.30 | ) | $ | (1.35 | ) | ||||
| Weighted average shares outstanding: | ||||||||||||||||
| Basic & diluted | 37,622,884 | 33,283,705 | 34,774,163 | 30,351,353 | ||||||||||||
| Total revenues: | $ | 15,370 | $ | 8,783 | $ | 50,157 | $ | 33,879 | ||||||||
| Adjustments: | ||||||||||||||||
| Fanapt licensing agreement | (7,765 | ) | (6,752 | ) | (30,746 | ) | (26,789 | ) | ||||||||
| Non-GAAP Total revenues | $ | 7,605 | $ | 2,031 | $ | 19,411 | $ | 7,090 | ||||||||
| Operating expenses: | $ | (54,323 | ) | $ | 16,574 | $ | 30,095 | $ | 55,079 | |||||||
| Adjustments: | ||||||||||||||||
| Cost of sales | (682 | ) | (1,583 | ) | ||||||||||||
| Stock based compensation | (1,631 | ) | (1,409 | ) | (5,878 | ) | (5,404 | ) | ||||||||
| Intangible asset amortization | (536 | ) | (377 | ) | (2,254 | ) | (1,495 | ) | ||||||||
| Gain on arbitration settlement | 77,616 | 77,616 | ||||||||||||||
| Non-GAAP Operating expenses, excluding Cost of sales | $ | 20,444 | $ | 14,788 | $ | 97,996 | $ | 48,180 | ||||||||
| Research and development: | $ | 4,752 | $ | 6,270 | $ | 19,230 | $ | 28,502 | ||||||||
| Adjustments: | ||||||||||||||||
| Stock based compensation | (556 | ) | (646 | ) | (1,933 | ) | (2,166 | ) | ||||||||
| Non-GAAP Research and development | $ | 4,196 | $ | 5,624 | $ | 17,297 | $ | 26,336 | ||||||||
| Selling, general and administrative: | $ | 17,323 | $ | 9,927 | $ | 84,644 | $ | 25,082 | ||||||||
| Adjustments: | ||||||||||||||||
| Stock based compensation | (1,075 | ) | (763 | ) | (3,945 | ) | (3,238 | ) | ||||||||
| Non-GAAP Selling, general and administrative | $ | 16,248 | $ | 9,164 | $ | 80,699 | $ | 21,844 |
Senior Vice President & Chief Financial
Vanda Pharmaceuticals Inc.
SOURCE Vanda Pharmaceuticals