"With another strong performance in Q3, Vanda is on target to achieve more than
HETLIOZ® (tasimelteon)
- HETLIOZ® net product sales grew to
$11.7 million in the third quarter of 2015, a 17% increase compared to$10.0 million in the second quarter of 2015 and a 124% increase compared to$5.2 million reported in the third quarter of 2014. - A Phase III study of HETLIOZ® for the treatment of Jet Lag Disorder is expected to begin in the first quarter of 2016.
- Preparations are ongoing for a 2016 European launch of HETLIOZ® for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24).
Fanapt® (iloperidone)
- Fanapt® net product sales of
$16.7 million during the third quarter of 2015 reflected a 5% decline as compared to net product sales of$17.6 million recorded in the second quarter of 2015 and a 1% decline compared to$16.9 million reported byNovartis for Fanapt® in the third quarter of 2014. - Since
August 2015 , five additional Fanapt® patents were listed in the U.S Food and Drug Administration's (FDA ) Orange Book further expanding the method of use patent portfolio for Fanapt® which now includes nine method patents with expiry dates that range from 2025 to 2031. - In
September 2015 , theFDA accepted for review a supplemental New Drug Application for Fanapt® for the maintenance treatment of schizophrenia in adults. TheFDA has set a PDUFA goal date inMay 2016 to complete its review. - Vanda expects to file for European regulatory approval of oral Fanapt® in the fourth quarter of 2015.
Cash, cash equivalents and marketable securities were
Non-GAAP Financial Results
Vanda Non-GAAP total revenues for the third quarter of 2015 were
For the third quarter of 2015, Non-GAAP net loss was
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."
Vanda Affirms 2015 Financial Guidance
Vanda is affirming its 2015 financial guidance and expects to achieve the following financial objectives in 2015:
- Combined net product sales from both HETLIOZ® and Fanapt® of between
$100 million and $115 million . - HETLIOZ® net product sales of between
$40 million to $45 million . - Fanapt® net product sales of between
$60 million to $70 million . - Non-GAAP Operating expenses, excluding cost of goods sold, of between
$100 million and $110 million .
Non-GAAP Operating expenses also excludes:
- Intangible asset amortization expense of
$13.0 million . - Stock-based compensation of between
$8.5 million and $10.5 million .
Full U.S. HETLIOZ® Prescribing Information can be found at: www.hetlioz.com.
Full U.S. Fanapt® Prescribing Information, including Boxed Warnings and Important Safety Information can be found at: www.fanapt.com.
Conference Call
Vanda has scheduled a conference call for today,
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 Total revenues" excludes Fanapt® licensing revenue. Vanda's "Non-GAAP Selling, general and administrative expenses" and "
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 2015 Non-GAAP Operating expenses, excluding cost of goods sold, a forward-looking Non-GAAP financial measure under the heading "2015 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 the Non-GAAP financial measures to their most directly comparable GAAP financial measure.
About
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 "Vanda Affirms 2015 Financial Guidance" above, and statements regarding Vanda's clinical plans for HETLIOZ®, Vanda's European commercial launch of HETLIOZ® and Vanda's U.S. and EU regulatory strategy for Fanapt®, 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 Vanda's forward-looking statements include, among others: Vanda's ability to successfully commercialize HETLIOZ® for the treatment of Non-24 in the U.S. and
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 for share and per share amounts) |
2015 |
2014 |
2015 |
2014 |
||||||||||||
Revenues: |
||||||||||||||||
HETLIOZ®product sales, net |
$ |
11,682 |
$ |
5,222 |
$ |
29,159 |
$ |
6,781 |
||||||||
Fanapt®product sales, net |
16,662 |
107 |
48,917 |
107 |
||||||||||||
Fanapt®royalty revenue |
- |
1,689 |
- |
4,919 |
||||||||||||
Fanapt®licensing revenue |
- |
7,764 |
- |
22,981 |
||||||||||||
Total revenues |
28,344 |
14,782 |
78,076 |
34,788 |
||||||||||||
Operating expenses: |
||||||||||||||||
Cost of goods sold |
6,510 |
703 |
17,291 |
901 |
||||||||||||
Research and development |
9,974 |
3,701 |
20,398 |
14,479 |
||||||||||||
Selling, general and administrative |
18,458 |
11,290 |
55,650 |
67,321 |
||||||||||||
Intangible asset amortization |
2,943 |
536 |
10,029 |
1,718 |
||||||||||||
Total operating expenses |
37,885 |
16,230 |
103,368 |
84,419 |
||||||||||||
Income (loss) from operations |
(9,541) |
(1,448) |
(25,292) |
(49,631) |
||||||||||||
Other income |
80 |
22 |
225 |
98 |
||||||||||||
Net income (loss) |
$ |
(9,461) |
$ |
(1,426) |
$ |
(25,067) |
$ |
(49,533) |
||||||||
Net income (loss) per share: |
||||||||||||||||
Basic and diluted |
$ |
(0.22) |
$ |
(0.04) |
$ |
(0.60) |
$ |
(1.46) |
||||||||
Weighted average shares outstanding: |
||||||||||||||||
Basic and diluted |
42,435,405 |
33,886,845 |
42,059,839 |
33,814,154 |
||||||||||||
VANDA PHARMACEUTICALS INC. |
||||||||||||
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) |
||||||||||||
($ in thousands) |
September 30, |
December 31, |
||||||||||
ASSETS |
||||||||||||
Current assets: |
||||||||||||
Cash and cash equivalents |
$ |
46,786 |
$ |
60,901 |
||||||||
Marketable securities |
97,529 |
68,921 |
||||||||||
Accounts receivable, net |
15,789 |
3,654 |
||||||||||
Inventory |
3,797 |
5,170 |
||||||||||
Prepaid expenses and other current assets |
9,976 |
3,084 |
||||||||||
Total current assets |
173,877 |
141,730 |
||||||||||
Property and equipment, net |
4,159 |
2,437 |
||||||||||
Intangible assets, net |
41,695 |
26,724 |
||||||||||
Restricted cash and other |
813 |
813 |
||||||||||
Total assets |
$ |
220,544 |
$ |
171,704 |
||||||||
LIABILITIES AND STOCKHOLDERS' EQUITY |
||||||||||||
Current liabilities: |
||||||||||||
Accounts payable and accrued liabilities |
$ |
45,889 |
$ |
7,786 |
||||||||
Total current liabilities |
45,889 |
7,786 |
||||||||||
Milestone obligation under license agreement |
25,000 |
- |
||||||||||
Other non-current liabilities |
3,718 |
3,101 |
||||||||||
Total liabilities |
74,607 |
10,887 |
||||||||||
Stockholders' equity: |
||||||||||||
Common stock |
43 |
41 |
||||||||||
Additional paid-in capital |
458,908 |
448,744 |
||||||||||
Accumulated other comprehensive income |
37 |
16 |
||||||||||
Accumulated deficit |
(313,051) |
(287,984) |
||||||||||
Total stockholders' equity |
145,937 |
160,817 |
||||||||||
Total liabilities and stockholders' equity |
$ |
220,544 |
$ |
171,704 |
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) |
2015 |
2014 |
2015 |
2014 |
||||||||||||
Net income (loss) |
$ |
(9,461) |
$ |
(1,426) |
$ |
(25,067) |
$ |
(49,533) |
||||||||
Adjustments: |
||||||||||||||||
Fanapt®licensing revenue |
- |
(7,764) |
- |
(22,981) |
||||||||||||
Stock-based compensation |
2,061 |
1,411 |
6,074 |
4,247 |
||||||||||||
Intangible asset amortization |
2,943 |
536 |
10,029 |
1,718 |
||||||||||||
Non-GAAP Net loss |
$ |
(4,457) |
$ |
(7,243) |
$ |
(8,964) |
$ |
(66,549) |
||||||||
Non-GAAP Net loss per share: |
||||||||||||||||
Basic and diluted |
$ |
(0.11) |
$ |
(0.21) |
$ |
(0.21) |
$ |
(1.97) |
||||||||
Weighted average shares outstanding: |
||||||||||||||||
Basic and diluted |
42,435,405 |
33,886,845 |
42,059,839 |
33,814,154 |
||||||||||||
Total revenues |
$ |
28,344 |
$ |
14,782 |
$ |
78,076 |
$ |
34,788 |
||||||||
Adjustment: |
||||||||||||||||
Fanapt®licensing revenue |
- |
(7,764) |
- |
(22,981) |
||||||||||||
Non-GAAP Total revenues |
$ |
28,344 |
$ |
7,018 |
$ |
78,076 |
$ |
11,807 |
||||||||
Operating expenses |
$ |
37,885 |
$ |
16,230 |
$ |
103,368 |
$ |
84,419 |
||||||||
Adjustments: |
||||||||||||||||
Cost of goods sold |
(6,510) |
(703) |
(17,291) |
(901) |
||||||||||||
Stock-based compensation |
(2,061) |
(1,411) |
(6,074) |
(4,247) |
||||||||||||
Intangible asset amortization |
(2,943) |
(536) |
(10,029) |
(1,718) |
||||||||||||
Non-GAAP Operating expenses |
$ |
26,371 |
$ |
13,580 |
$ |
69,974 |
$ |
77,553 |
||||||||
excluding Cost of goods sold |
||||||||||||||||
Research and development |
$ |
9,974 |
$ |
3,701 |
$ |
20,398 |
$ |
14,479 |
||||||||
Adjustment: |
||||||||||||||||
Stock-based compensation |
(516) |
(442) |
(1,743) |
(1,377) |
||||||||||||
Non-GAAP Research and development |
$ |
9,458 |
$ |
3,259 |
$ |
18,655 |
$ |
13,102 |
||||||||
Selling, general and administrative |
$ |
18,458 |
$ |
11,290 |
$ |
55,650 |
$ |
67,321 |
||||||||
Adjustment: |
||||||||||||||||
Stock-based compensation |
(1,545) |
(969) |
(4,331) |
(2,870) |
||||||||||||
Non-GAAP Selling, general and administrative |
$ |
16,913 |
$ |
10,321 |
$ |
51,319 |
$ |
64,451 |
COMPANY CONTACT:
Senior Vice President & Chief Financial Officer
(202) 734-3428
jim.kelly@vandapharma.com
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/vanda-pharmaceuticals-reports-third-quarter-2015-financial-results-300171512.html
SOURCE