- HETLIOZ® U.S. sales grew to $5.2 million in the first full quarter since launch
- HETLIOZAccess™ Named Patient Program launched in Europe and Canada
- Fanapt® generated first ex-U.S. product revenue
"Our innovative approach to the commercialization of HETLIOZ® for Non-24 has yielded impressive third quarter revenue. We are developing a robust commercial engine that has just begun to access the Non-24 market in the U.S. by creating awareness leading to diagnosis and treatment," said
"Our commercial and clinical pipeline is also advancing with the recent launch of Fanapt® in
Key Highlights:
HETLIOZ® (tasimelteon)
- HETLIOZ® U.S. sales grew to
$5.2 million in the first full quarter since launch. HETLIOZ® is the first approved treatment for adults with Non-24-Hour Sleep-Wake Disorder (Non-24). - Over 600 new patient prescriptions have been written for HETLIOZ® in the U.S.
- HETLIOZ® Marketing Authorization Application in the
European Union (EU) was accepted by theEuropean Medicines Agency (EMA) for review inJune 2014 ; Vanda expects a regulatory decision in the third quarter of 2015. - In
September 2014 , the HETLIOZAccess™ Named Patient Program launched in the EU andCanada . Vanda has launched the HETLIOZAccess™ program in geographic locations where HETLIOZ® is not yet approved but where the company is pursuing regulatory approvals.
Fanapt® (iloperidone)
- Fanapt® generated first ex-U.S. product revenue of
$0.1 million . Fanapt® was launched inIsrael by our distribution partner, Megapharm. Fanapt® is expected to launch later this year inMexico by our distribution partner, Probiomed.
Clinical pipeline advances
- Non-24 pediatric population (tasimelteon). Vanda has initiated development activities for a pediatric formulation to be studied in pediatric patients with Non-24. Vanda has also initiated discussions with the
U.S. Food and Drug Administration (FDA ) and the EMA on clinical protocol designs for this indication. - Smith-Magenis Syndrome (SMS) (tasimelteon). SMS is a rare genetic disorder caused by a deletion on chromosome 17 and estimated to affect approximately 1 in 20,000 people. One of the cardinal features is a disruption of the sleep-wake cycle. Vanda has initiated an observational study in patients with SMS in order to further characterize the circadian rhythm defect and its association with clinical symptoms. Results of this study are expected in the first half of 2015.
- Chronic Pruritus (VLY-686, tradipitant). Vanda's Phase 2 study (2101), a double masked randomized study of tradipitant and placebo in patients with chronic pruritus in the context of atopic dermatitis, is ongoing in
Germany . Results from this study are expected in the first half of 2015. In August of 2014, an Investigational New Drug application was filed with theFDA .
THIRD QUARTER 2014 REPORTED RESULTS
Total revenues for the third quarter of 2014 were
Total operating expenses for the third quarter of 2014 were
Cash, cash equivalents and marketable securities were
REVISED 2014 FINANCIAL GUIDANCE
- Total 2014 operating expenses are expected to be between
$105.0 and $110.0 million . Prior guidance for operating expenses was between$110.0 and $120.0 million . - Total 2014 operating expenses include intangible asset amortization expense of
$2.3 million and approximately$6.0 million of non-cash stock based compensation. Prior guidance for stock based compensation was between$6.0 and $8.0 million .
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 "REVISED 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 |
Nine Months Ended | ||||||||||||||
September 30, |
September 30, |
September 30, |
September 30, | ||||||||||||
($ in thousands, except per share amounts) |
2014 |
2013 (1) |
2014 |
2013 (1) | |||||||||||
Revenues: |
|||||||||||||||
HETLIOZ® product revenue, net(2) |
$ |
5,222 |
$ |
- |
$ |
6,781 |
$ |
- | |||||||
Fanapt® product revenue, net (ex-U.S.) |
107 |
- |
107 |
- | |||||||||||
Fanapt® royalty revenue |
1,689 |
1,956 |
4,919 |
5,059 | |||||||||||
Fanapt® licensing agreement (3) |
7,764 |
6,753 |
22,981 |
20,037 | |||||||||||
Total revenues |
14,782 |
8,709 |
34,788 |
25,096 | |||||||||||
Operating expenses: |
|||||||||||||||
Cost of sales(4) |
703 |
- |
901 |
- | |||||||||||
Research and development |
3,701 |
8,022 |
14,479 |
22,233 | |||||||||||
Selling, general and administrative |
11,290 |
5,741 |
67,321 |
15,154 | |||||||||||
Intangible asset amortization |
536 |
377 |
1,718 |
1,118 | |||||||||||
Total operating expenses |
16,230 |
14,140 |
84,419 |
38,505 | |||||||||||
Loss from operations |
(1,448) |
(5,431) |
(49,631) |
(13,409) | |||||||||||
Other income |
22 |
25 |
98 |
101 | |||||||||||
Net loss |
$ |
(1,426) |
$ |
(5,406) |
$ |
(49,533) |
$ |
(13,308) | |||||||
Net loss per share: |
|||||||||||||||
Basic and diluted |
$ |
(0.04) |
$ |
(0.17) |
$ |
(1.46) |
$ |
(0.45) | |||||||
Shares used in calculations of net loss |
|||||||||||||||
per share: |
|||||||||||||||
Basic and diluted |
33,886,845 |
31,332,993 |
33,814,154 |
29,363,162 |
(1) |
Prior year amounts have been restated to reflect a change in accounting method for the attribution of stock-based compensation. Refer |
(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 $200 million upfront payment received from Novartis for the right to |
(4) |
Cost of sales includes physical product costs plus for HETLIOZ® includes a 10% royalty to Bristol-Myers Squibb and for Fanapt® includes |
VANDA PHARMACEUTICALS INC. | ||||||||||||
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) | ||||||||||||
($ in thousands) |
September 30, |
December 31, | ||||||||||
ASSETS |
||||||||||||
Current assets: |
||||||||||||
Cash and cash equivalents |
$ |
15,308 |
$ |
64,764 | ||||||||
Marketable securities |
40,781 |
65,586 | ||||||||||
Accounts receivable |
3,696 |
2,031 | ||||||||||
Inventory |
1,268 |
- | ||||||||||
Prepaid expenses and other current assets |
3,785 |
2,703 | ||||||||||
Restricted cash |
- |
530 | ||||||||||
Total current assets |
64,838 |
135,614 | ||||||||||
Property and equipment, net |
2,233 |
2,198 | ||||||||||
Intangible asset, net |
11,319 |
5,037 | ||||||||||
Restricted cash, non-current |
785 |
500 | ||||||||||
Total assets |
$ |
79,175 |
$ |
143,349 | ||||||||
LIABILITIES AND STOCKHOLDERS' EQUITY |
||||||||||||
Current liabilities: |
||||||||||||
Accounts payable |
$ |
547 |
$ |
661 | ||||||||
Accrued liabilities |
6,825 |
5,180 | ||||||||||
Deferred rent |
241 |
221 | ||||||||||
Deferred revenues |
31,232 |
26,789 | ||||||||||
Total current liabilities |
38,845 |
32,851 | ||||||||||
Deferred rent, non-current |
2,919 |
2,888 | ||||||||||
Deferred revenues, non-current |
36,235 |
63,486 | ||||||||||
Other liabilities |
113 |
- | ||||||||||
Total liabilities |
78,112 |
99,225 | ||||||||||
Stockholders' equity: |
||||||||||||
Common stock |
34 |
33 | ||||||||||
Additional paid-in capital |
358,728 |
352,240 | ||||||||||
Accumulated other comprehensive income |
4 |
21 | ||||||||||
Accumulated deficit |
(357,703) |
(308,170) | ||||||||||
Total stockholders' equity |
1,063 |
44,124 | ||||||||||
Total liabilities and stockholders' equity |
$ |
79,175 |
$ |
143,349 |
(1) Prior year amounts have been restated to reflect a change in accounting method for the attribution of |
INVESTOR CONTACT:
Vice President
The Trout Group
(646) 378-2947
crubin@troutgroup.com
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/vanda-pharmaceuticals-reports-third-quarter-2014-financial-results-255894914.html
SOURCE