"2014 was a 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
Key Highlights:
HETLIOZ® (tasimelteon)
- HETLIOZ® net product sales in the U.S. grew to
$6.0 million in the fourth quarter of 2014, a 15% increase, compared to$5.2 million in the third quarter of 2014. HETLIOZ® net product sales were$12.8 million for the full year 2014. - Since the U.S. commercial launch of HETLIOZ® in
April 2014 , over 760 new patient prescriptions have been written including over 220 in the fourth quarter of 2014. As ofDecember 31, 2014 , over 470 patients had initiated HETLIOZ® treatment and over 330 patients were on active treatment reflecting a cumulative persistence rate of approximately 70%. - The HETLIOZ® Marketing Authorization Application in the
European Union (EU) is under review with a regulatory decision expected in the third quarter of 2015. - Tasimelteon life cycle management activities are ongoing and include a Smith-Magenis Syndrome observational study with results expected in the first half of 2015 and preparations for a clinical development program for pediatric Non-24.
- HETLIOZ® exclusivity in the U.S. is protected by orphan exclusivity and two patents listed in the FDA Orange Book (Orphan exclusivity expiry in 2021; Patent No. 5,856,529 expiry expected in 2022 and Patent No. 8,785,492 expiry in 2033).
Fanapt® (iloperidone)
- Fanapt® royalty revenue was
$1.6 million for the fourth quarter of 2014, compared to$1.7 million in the third quarter of 2014. Fanapt® royalty revenue was$6.5 million for the full year 2014, compared to$7.1 million for 2013. - For the full year 2014, Fanapt® U.S. net product sales were
$65.0 million , as reported byNovartis AG (Novartis). Fanapt® U.S. prescriptions for the fourth quarter of 2014 were approximately 40,500, as reported by IMS. - On
December 31, 2014 , the Fanapt® U.S. and Canadian rights were returned to Vanda as part of the settlement of arbitration withNovartis . - Fanapt® exclusivity in the U.S. is protected by two patents listed in the FDA Orange Book (Patent No. RE39198 expiry in 2016 and Patent No. 8,586,610 expiry in 2027).
VLY-686 (tradipitant)
- Results of the Phase II study (2101) of tradipitant, an NK1 receptor antagonist, in patients with chronic pruritus are expected in the first quarter of 2015.
Financial Results for the Fourth Quarter and Full Year 2014
Vanda total revenues for the fourth quarter of 2014 were
Selling, general and administrative expenses were
Research and development expenses were
Vanda recorded a
Vanda net income was
In
Non-GAAP Financial Results
Vanda Non-GAAP Total revenues for the fourth quarter of 2014 were
Vanda Non-GAAP Net loss was
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:
- Combined net product sales from both HETLIOZ® and Fanapt® of between
$95 million and $110 million . - HETLIOZ® net product sales of between
$40 million to $45 million and Fanapt® net product sales of between$55 million to $65 million . - Non-GAAP Operating expenses, excluding cost of sales, of between
$105 million and $120 million .
In addition, 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.
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 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.
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 "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
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 |
|||||||||||||||
December 31, |
December 31, |
December 31, |
December 31, |
|||||||||||||
($ in thousands, except per share amounts) |
2014 |
2013 (1) |
2014 |
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, |
December 31, |
||||||||||
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 |
Reconciliation of GAAP to Non-GAAP Financial Information |
||||||||||||||||
VANDA PHARMACEUTICALS INC. |
||||||||||||||||
Reconciliation of GAAP to Non-GAAP Financial Information |
||||||||||||||||
Three Months Ended |
Twelve Months Ended |
|||||||||||||||
December 31, |
December 31, |
December 31, |
December 31, |
|||||||||||||
($ in thousands, except per share amounts) |
2014 |
2013 (1) |
2014 |
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, |
$ |
20,444 |
$ |
14,788 |
$ |
97,996 |
$ |
48,180 |
||||||||
excluding Cost of sales |
||||||||||||||||
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 |
||||||||
(1) Prior year amounts have been restated to reflect a change in accounting method for the attribution of stock-based compensation. Refer to the notes to the consolidated financial statements included in the annual report on Form 10-K for the year ending December 31, 2014 to be filed with the SEC. |
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-fourth-quarter-2014-and-full-year-2014-financial-results-300038319.html
SOURCE