"We had another year of outstanding commercial growth," said
Key Financial Highlights
- Total revenues were
$60.9 million in the fourth quarter of 2019, a 15% increase compared to$53.0 million in the fourth quarter of 2018. Total revenues were$227.2 million for the full year 2019, an 18% increase compared$193.1 million for the full year 2018. - HETLIOZ® net product sales were
$38.6 million in the fourth quarter of 2019, a 19% increase compared to$32.4 million in the fourth quarter of 2018. HETLIOZ® net product sales were$143.0 million for the full year 2019, a 23% increase compared to$115.8 million for the full year 2018. - Fanapt® net product sales were
$22.3 million in the fourth quarter of 2019, an 8% increase compared to$20.6 million in the fourth quarter of 2018. Fanapt® net product sales were$84.2 million for the full year 2019, a 9% increase compared to$77.3 million for the full year 2018. - Cash, cash equivalents and marketable securities (Cash) were
$312.1 million as ofDecember 31, 2019 , representing an increase to Cash of$54.8 million compared toDecember 31, 2018 .
Key Product and Pipeline Highlights
Tradipitant
- Results from the EPIONE study of tradipitant in the treatment of pruritus in atopic dermatitis were reported today. Vanda will reassess EPIONE 2 and determine next steps.
- Enrollment in the Phase III study of tradipitant in gastroparesis (VP-VLY-686-3301) is ongoing.
- Vanda expects to complete the Phase III program of tradipitant in motion sickness and file a New Drug Application with the
U.S. Food and Drug Administration (FDA) in 2020. - Vanda continues to engage with the FDA over the requirement of a 9-month dog toxicity study.
HETLIOZ® (tasimelteon)
- Vanda submitted a supplemental New Drug Application (sNDA) for HETLIOZ® in Smith-Magenis Syndrome (SMS), including data for a liquid formulation, and expects regulatory action by the FDA in 2020.
- Vanda continues to pursue approval for HETLIOZ® in the treatment of jet lag disorder (JLD).
- A clinical program for HETLIOZ® in delayed sleep phase disorder (DSPD) is ongoing.
Fanapt® (iloperidone)
- A Phase III study of Fanapt® in bipolar disorder is ongoing.
- Development of the long acting injectable (LAI) formulation of Fanapt® is ongoing.
GAAP Financial Results
Net income was
Net income was
2020 Financial Guidance
Vanda expects to achieve the following financial objectives in 2020:
Full Year 2020 Financial Objectives |
Full Year 2020 Guidance |
Total revenues
|
|
HETLIOZ® net product sales
|
|
Fanapt® net product sales
|
|
Year-end 2020 Cash |
Greater than |
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 Investors 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
Vanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. For more on
CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS
Various statements in this release, including, but not limited to, the guidance provided under "2020 Financial Guidance" above, are "forward-looking statements" under the securities laws. 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 assumptions regarding its ability to continue to grow its business in the
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.
|
||||||||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
||||||||||||||||
(in thousands, except for share and per share amounts) |
||||||||||||||||
(unaudited) |
||||||||||||||||
Three Months Ended |
Twelve Months Ended |
|||||||||||||||
|
|
|
|
|||||||||||||
2019 |
2018 |
2019 |
2018 |
|||||||||||||
Revenues: |
||||||||||||||||
HETLIOZ®product sales, net |
$ |
38,599 |
$ |
32,444 |
$ |
142,980 |
$ |
115,835 |
||||||||
Fanapt®product sales, net |
22,331 |
20,597 |
84,208 |
77,283 |
||||||||||||
Total revenues |
60,930 |
53,041 |
227,188 |
193,118 |
||||||||||||
Operating expenses: |
||||||||||||||||
Cost of goods sold excluding amortization |
6,225 |
5,667 |
24,488 |
20,508 |
||||||||||||
Research and development |
13,074 |
12,922 |
48,649 |
43,594 |
||||||||||||
Selling, general and administrative |
37,018 |
24,922 |
129,736 |
105,751 |
||||||||||||
Intangible asset amortization |
370 |
380 |
1,505 |
1,527 |
||||||||||||
Total operating expenses |
56,687 |
43,891 |
204,378 |
171,380 |
||||||||||||
Income from operations |
4,243 |
9,150 |
22,810 |
21,738 |
||||||||||||
Other income |
1,567 |
1,168 |
6,218 |
3,608 |
||||||||||||
Income before income taxes |
5,810 |
10,318 |
29,028 |
25,346 |
||||||||||||
Provision (benefit) for income taxes |
1,594 |
(42) |
(86,525) |
138 |
||||||||||||
Net income |
$ |
4,216 |
$ |
10,360 |
$ |
115,553 |
$ |
25,208 |
||||||||
Net income per share, basic |
$ |
0.08 |
$ |
0.20 |
$ |
2.17 |
$ |
0.50 |
||||||||
Net income per share, diluted |
$ |
0.08 |
$ |
0.19 |
$ |
2.11 |
$ |
0.48 |
||||||||
Weighted average shares outstanding, basic |
53,389,950 |
52,457,275 |
53,137,562 |
50,859,947 |
||||||||||||
Weighted average shares outstanding, diluted |
54,973,952 |
55,216,507 |
54,847,060 |
53,045,257 |
|
||||||||||||
CONDENSED CONSOLIDATED BALANCE SHEETS |
||||||||||||
(in thousands) |
||||||||||||
(unaudited) |
||||||||||||
|
|
|||||||||||
ASSETS |
||||||||||||
Current assets: |
||||||||||||
Cash and cash equivalents |
$ |
45,072 |
$ |
61,005 |
||||||||
Marketable securities |
267,057 |
196,355 |
||||||||||
Accounts receivable, net |
26,367 |
28,780 |
||||||||||
Inventory |
1,140 |
994 |
||||||||||
Prepaid expenses and other current assets |
14,500 |
11,998 |
||||||||||
Total current assets |
354,136 |
299,132 |
||||||||||
Property and equipment, net |
3,864 |
4,417 |
||||||||||
Operating lease right-of-use assets |
11,180 |
- |
||||||||||
Intangible assets, net |
23,037 |
24,542 |
||||||||||
Deferred tax assets |
87,680 |
- |
||||||||||
Non-current inventory and other |
3,851 |
4,039 |
||||||||||
Total assets |
$ |
483,748 |
$ |
332,130 |
||||||||
LIABILITIES AND STOCKHOLDERS' EQUITY |
||||||||||||
Current liabilities: |
||||||||||||
Accounts payable and accrued liabilities |
$ |
27,590 |
$ |
21,584 |
||||||||
Product revenue allowances |
31,915 |
31,231 |
||||||||||
Milestone obligations under license agreements |
- |
200 |
||||||||||
Total current liabilities |
59,505 |
53,015 |
||||||||||
Operating lease non-current liabilities |
12,455 |
- |
||||||||||
Other non-current liabilities |
843 |
3,693 |
||||||||||
Total liabilities |
72,803 |
56,708 |
||||||||||
Stockholders' equity: |
||||||||||||
Common stock |
54 |
52 |
||||||||||
Additional paid-in capital |
631,307 |
611,587 |
||||||||||
Accumulated other comprehensive income |
249 |
1 |
||||||||||
Accumulated deficit |
(220,665) |
(336,218) |
||||||||||
Total stockholders' equity |
410,945 |
275,422 |
||||||||||
Total liabilities and stockholders' equity |
$ |
483,748 |
$ |
332,130 |
||||||||
(1) |
With the adoption of Accounting Standards Codification Subtopic ASC 842, Leases, on |
Corporate Contact:
AJ Jones II
Chief Corporate Affairs and Communications Officer
202-734-3400
pr@vandapharma.com
Head of Corporate Affairs
202-734-3400
pr@vandapharma.com
View original content:http://www.prnewswire.com/news-releases/vanda-pharmaceuticals-reports-fourth-quarter-and-full-year-2019-financial-results-301011156.html
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