"We are encouraged by the early positive reception of HETLIOZ by patients, physicians and payors. We look forward to more patients benefiting from HETLIOZ in the coming months and years," said
Key Highlights:
- As of
August 6, 2014 , over 420 new patient prescriptions have been written for HETLIOZ®(tasimelteon) in the U.S. - In
June 2014 , Vanda announced that theEuropean Medicines Agency (EMA) accepted for evaluation the Marketing Authorization Application for oral HETLIOZ® capsules for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24). - In
July 2014 , the U.S. Patent and Trademark Office (USPTO) issued a new method of use patent for HETLIOZ® in the treatment of Non-24.
SECOND QUARTER 2014 REPORTED RESULTS
Total revenues for the second quarter of 2014 were
Total operating expenses for the second quarter of 2014 were
Cash, cash equivalents and marketable securities (Cash) were
Year to Date
Six Months Ended |
|||||||
June 30, |
June 30, |
||||||
($ in thousands, except per share amounts) |
2014 |
2013 |
Change ($) |
Change (%) |
|||
Total revenues |
$ 20,005 |
$ 16,387 |
$ 3,618 |
22% |
|||
Research & development expenses |
10,777 |
14,211 |
(3,434) |
(24%) |
|||
Selling, general & administrative expenses |
56,032 |
9,413 |
46,619 |
495% |
|||
Non-cash stock-based compensation (3) |
2,836 |
2,432 |
404 |
17% |
|||
Net loss |
(48,108) |
(7,902) |
(40,206) |
(509%) |
|||
Diluted net loss per share |
$ (1.42) |
$ (0.28) |
$ (1.14) |
(407%) |
Second Quarter 2014 Key Financial Figures(1) (2)
Three Months Ended |
|||||||
June 30, |
March 31, |
||||||
($ in thousands, except per share amounts) |
2014 |
2014 |
Change ($) |
Change (%) |
|||
Total revenues |
$ 10,862 |
$ 9,143 |
$ 1,719 |
19% |
|||
Research & development expenses |
3,514 |
7,263 |
(3,749) |
(52%) |
|||
Selling, general & administrative expenses |
28,139 |
27,893 |
246 |
1% |
|||
Non-cash stock-based compensation (3) |
1,443 |
1,393 |
50 |
4% |
|||
Net loss |
(21,575) |
(26,533) |
4,958 |
19% |
|||
Diluted net loss per share |
$ (0.64) |
$ (0.79) |
$ 0.15 |
19% |
Select Cash Flow Data(1)(2)
Six Months Ended |
|||
June 30, |
June 30, |
||
($ in thousands) |
2014 |
2013 |
|
Net cash provided by (used in) |
|||
Operating activities |
$ (60,569) |
$ (17,168) |
|
Investing activities |
10,756 |
31,428 |
|
Financing activities |
2,043 |
601 |
Select Balance Sheet Data(1)
June 30, |
December 31 |
June 30, |
|||
($ in thousands) |
2014 |
2013 |
2013 |
||
Total Cash(4) |
$ 63,585 |
$ 130,350 |
$ 103,633 |
(1) Unaudited. |
(2) Prior year amounts have been restated to reflect a change in accounting method for the attribution of stock-based compensation. Refer to footnote 3 in the quarterly report on Form 10Q for the quarter ending June 30, 2014. |
(3) Non-cash stock-based compensation is allocated to both Research & development and Selling, general & administrative expenses. |
(4) Total Cash reflects cash, cash equivalents and marketable securities |
OPERATIONAL HIGHLIGHTS
As of
On
In
Vanda has initiated development activities for the use of HETLIOZ® in the pediatric population with Non-24, as well as in patients with Smith-Magenis syndrome.
The VLY-686, NK1 antagonist, Phase 2 study in chronic pruritus is ongoing and results are expected in mid-2015.
2014 FINANCIAL GUIDANCE
Total 2014 operating expenses are expected to be between
Full HETLIOZ® Prescribing Information can be found at: www.hetlioz.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.
ABOUT
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
Various statements in this release, including, but not limited to, the guidance provided under "2014 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 (Unaudited) |
|||||||||||||||
Three Months Ended |
Six Months Ended |
||||||||||||||
June 30, |
June 30, |
June 30, |
June 30, |
||||||||||||
($ in thousands, except per share amounts) |
2014 |
2013 (1) |
2014 |
2013 (1) |
|||||||||||
Revenues: |
|||||||||||||||
HETLIOZ®product revenue(2) |
$ |
1,559 |
$ |
- |
$ |
1,559 |
$ |
- |
|||||||
Fanapt®royalty revenue |
1,539 |
1,641 |
3,230 |
3,103 |
|||||||||||
Fanapt®licensing agreement (3) |
7,764 |
6,678 |
15,216 |
13,284 |
|||||||||||
Total revenues |
10,862 |
8,319 |
20,005 |
16,387 |
|||||||||||
Operating expenses: |
|||||||||||||||
Cost of sales |
198 |
- |
198 |
- |
|||||||||||
Research and development |
3,514 |
6,100 |
10,777 |
14,211 |
|||||||||||
Selling, general and administrative |
28,139 |
5,260 |
56,032 |
9,413 |
|||||||||||
Intangible asset amortization |
617 |
372 |
1,182 |
741 |
|||||||||||
Total operating expenses |
32,468 |
11,732 |
68,189 |
24,365 |
|||||||||||
Loss from operations |
(21,606) |
(3,413) |
(48,184) |
(7,978) |
|||||||||||
Other income |
31 |
30 |
76 |
76 |
|||||||||||
Loss before tax benefit |
(21,575) |
(3,383) |
(48,108) |
(7,902) |
|||||||||||
Tax benefit |
- |
- |
- |
- |
|||||||||||
Net loss |
$ |
(21,575) |
$ |
(3,383) |
$ |
(48,108) |
$ |
(7,902) |
|||||||
Net loss per share: |
|||||||||||||||
Basic and diluted |
$ |
(0.64) |
$ |
(0.12) |
$ |
(1.42) |
$ |
(0.28) |
|||||||
Shares used in calculations of net loss |
|||||||||||||||
per share: |
|||||||||||||||
Basic and diluted |
33,874,625 |
28,377,254 |
33,777,207 |
28,361,340 |
|||||||||||
(1) Prior year amounts have been restated to reflect a change in accounting method for the attribution of stock-based compensation. Refer to footnote 3 in the quarterly report on Form 10Q for the quarter ending June 30, 2014. |
|||||||||||||||
(2) HETLIOZ® product revenue is recognized upon delivery of product shipments to the specialty pharmacies. |
|||||||||||||||
(3) Fanapt® licensing agreement revenue reflects the amortization of the $200 million upfront payment received from Novartis for the right to commercialize and develop Fanapt® in the U.S. and Canada. |
VANDA PHARMACEUTICALS INC. |
||||||||||||
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) |
||||||||||||
($ in thousands) |
June 30, |
December 31, |
||||||||||
ASSETS |
||||||||||||
Current assets: |
||||||||||||
Cash and cash equivalents |
$ |
16,994 |
$ |
64,764 |
||||||||
Marketable securities |
46,591 |
65,586 |
||||||||||
Accounts receivable |
2,376 |
2,031 |
||||||||||
Inventory |
1,093 |
- |
||||||||||
Prepaid expenses and other current assets |
4,166 |
2,703 |
||||||||||
Restricted cash |
- |
530 |
||||||||||
Total current assets |
71,220 |
135,614 |
||||||||||
Property and equipment, net |
2,312 |
2,198 |
||||||||||
Intangible asset, net |
11,855 |
5,037 |
||||||||||
Restricted cash, non-current |
785 |
500 |
||||||||||
Total assets |
$ |
86,172 |
$ |
143,349 |
||||||||
LIABILITIES AND STOCKHOLDERS' EQUITY |
||||||||||||
Current liabilities: |
||||||||||||
Accounts payable |
$ |
248 |
$ |
661 |
||||||||
Accrued liabilities |
6,753 |
5,180 |
||||||||||
Deferred rent |
234 |
221 |
||||||||||
Deferred revenues |
31,059 |
26,789 |
||||||||||
Total current liabilities |
38,294 |
32,851 |
||||||||||
Deferred rent, non-current |
2,853 |
2,888 |
||||||||||
Deferred revenues, non-current |
44,000 |
63,486 |
||||||||||
Other liabilities |
140 |
- |
||||||||||
Total liabilities |
85,287 |
99,225 |
||||||||||
Stockholders' equity: |
||||||||||||
Common stock |
34 |
33 |
||||||||||
Additional paid-in capital |
357,119 |
352,240 |
||||||||||
Accumulated other comprehensive income |
10 |
21 |
||||||||||
Accumulated deficit |
(356,278) |
(308,170) |
||||||||||
Total stockholders' equity |
885 |
44,124 |
||||||||||
Total liabilities and stockholders' equity |
$ |
86,172 |
$ |
143,349 |
||||||||
(1) Prior year amounts have been restated to reflect a change in accounting method for the attribution of stock-based compensation. Refer to footnote 3 in the quarterly report on Form 10Q for the quarter ending June 30, 2014. |
INVESTOR CONTACT:
Vice President
The Trout Group
(646) 378-2947
crubin@troutgroup.com
SOURCE