WASHINGTON, Nov. 7, 2018 /PRNewswire/ -- Vanda
Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced
financial and operational results for the third quarter ended
September 30, 2018.
Key Highlights:
- Vanda reiterates 2018 net product sales guidance of
$180 million to $200 million.
- Total net product sales from HETLIOZ® and
Fanapt® were $49.1 million
during the third quarter of 2018, a 4% increase compared to
$47.4 million in the second quarter
of 2018 and a 19% increase compared to $41.3
million in the third quarter of 2017.
HETLIOZ® (tasimelteon)
- HETLIOZ® net product sales were $29.9 million in the third quarter of 2018, a 7%
increase compared to $28.0 million in
the second quarter of 2018 and a 34% increase compared to
$22.3 million in the third quarter of
2017.
Fanapt® (iloperidone)
- Fanapt® net product sales were $19.2 million in the third quarter of 2018, a
less than 1% decrease compared to $19.3
million in the second quarter of 2018 and a less than 1%
increase compared to $19.1 million in
the third quarter of 2017.
Research and Development
Tradipitant
- Enrollment in the clinical study of tradipitant in
gastroparesis is complete. Results are expected by the end of
2018.
- The Phase III study (EPIONE) of tradipitant in atopic
dermatitis is ongoing.
HETLIOZ® (tasimelteon)
- Enrollment in the clinical study of HETLIOZ® in
Smith-Magenis Syndrome is complete. Results are expected by the end
of 2018.
- Vanda submitted a supplemental New Drug Application (sNDA) to
the U.S. Food and Drug Administration for HETLIOZ® in
jet lag disorder and expects a filing date by the end of 2018.
- In September, a HETLIOZ® driving studying
demonstrated no impairment of next day driving performance.
Fanapt® (iloperidone)
- A pharmacokinetic study of the long acting injectable (Depot)
formulation of Fanapt® enrolled its first patient during
October 2018.
VTR-297 (histone deacetylase (HDAC) inhibitor)
- The Phase I study (1101) of VTR-297 in patients with
hematologic malignancies randomized its first patient in
October 2018.
Cash, cash equivalents and marketable securities (Cash) were
$240.6 million as of September 30, 2018. During the third
quarter of 2018, Cash increased by $9.4
million.
Non-GAAP Financial Results
For the third quarter of 2018, Non-GAAP net income was
$10.4 million, compared to Non-GAAP
net loss of $1.3 million for the
third quarter of 2017.
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."
2018 Financial Guidance
Vanda reiterates its prior 2018 net product sales guidance and
provides an update to Non-GAAP Operating Expenses, Intangible Asset
Amortization and Year-End 2018 Cash guidance and expects to achieve
the following financial objectives in 2018:
Full Year
2018
Financial
Objectives
|
Full Year
2018
Guidance
|
Combined net product
sales from
both HETLIOZ® and Fanapt®
|
$180 to $200
million
|
HETLIOZ®
net product sales
|
$108 to $118
million
|
Fanapt®
net product sales
|
$72 to $82
million
|
Non-GAAP Operating
expenses,
excluding Cost of goods sold
|
$140 to $150
million
as compared to prior
guidance of
$153 to $163 million
|
Intangible asset
amortization
|
$1.5
million
as compared to prior
guidance of
$1.7
million
|
Stock-based
compensation
|
$11 to $15
million
|
Year-end 2018
Cash
|
$240 to $250
million
as compared to prior
guidance of
$225 to $235
million
|
Conference Call
Vanda has scheduled a conference call for today, Wednesday, November 7, 2018, at 4:30 PM ET. During the call, Vanda's
management will discuss the third quarter 2018 financial results
and other corporate activities. Investors can call 1-888-771-4371
(domestic) or 1-847-585-4405 (international) and use passcode
47697858. A replay of the call will be available on Wednesday, November 7, 2018, beginning at
7:00 PM ET and will be accessible
until Wednesday, November 14, 2018,
at 11:59 PM ET. The replay call-in
number is 1-888-843-7419 for domestic callers and 1-630-652-3042
for international callers. The passcode number is 47697858.
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 Selling, general and administrative expenses" and
"Non-GAAP Research and development expenses" exclude stock-based
compensation. Vanda's "Non-GAAP Net income (loss)," "Non-GAAP Net
income (loss) per share" and "Non-GAAP Operating expenses excluding
Cost of goods sold" exclude stock-based compensation and intangible
asset amortization.
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 2018 Non-GAAP
Operating expenses, excluding Cost of goods sold, a forward-looking
Non-GAAP financial measure under the heading "2018 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 our
Non-GAAP financial measures to their most directly comparable GAAP
financial measure.
About Vanda Pharmaceuticals Inc.
Vanda is a 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 Vanda Pharmaceuticals Inc., please
visit www.vandapharma.com.
CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS
Various statements in this release, including, but not limited
to, the guidance provided under "2018 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 U.S., Vanda's
ability to complete the clinical development and obtain regulatory
approval of tradipitant for the treatment of atopic dermatitis and
the treatment of gastroparesis, Vanda's ability to successfully
commercialize HETLIOZ® in Europe and other factors that are described in
the "Risk Factors" and "Management's Discussion and Analysis of
Financial Condition and Results of Operations" sections of Vanda's
annual report on Form 10-K for the fiscal year ended December 31, 2017 and quarterly report on Form
10-Q for the quarter ended June 30,
2018, which are on file with the SEC and available on the
SEC's website at www.sec.gov. Additional factors may be described
in those sections of Vanda's quarterly report on Form 10-Q for the
quarter ended September 30, 2018, to
be filed with the SEC in the fourth quarter of 2018. In addition to
the risks described above and in Vanda's annual report on Form 10-K
and quarterly reports on Form 10-Q, other unknown or unpredictable
factors also could affect Vanda's results. There can be no
assurance that the actual results or developments anticipated by
Vanda will be realized or, even if substantially realized, that
they will have the expected consequences to, or effects on, Vanda.
Therefore, no assurance can be given that the outcomes stated in
such forward-looking statements and estimates will be achieved.
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
|
(in thousands,
except for share and per share amounts)
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
Nine Months
Ended
|
|
|
|
|
|
September
30
|
|
September
30
|
|
September
30
|
|
September
30
|
|
|
|
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
HETLIOZ®product sales, net
|
|
$
|
29,923
|
|
$
|
22,279
|
|
$
|
83,391
|
|
$
|
64,968
|
|
Fanapt®product sales, net
|
|
|
19,212
|
|
|
19,057
|
|
|
56,686
|
|
|
55,839
|
|
|
Total
revenues
|
|
|
|
49,135
|
|
|
41,336
|
|
|
140,077
|
|
|
120,807
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold
excluding amortization
|
|
5,068
|
|
|
4,525
|
|
|
14,841
|
|
|
13,057
|
|
Research and
development
|
|
|
11,390
|
|
|
10,178
|
|
|
30,672
|
|
|
28,393
|
|
Selling, general and
administrative
|
|
|
26,047
|
|
|
31,124
|
|
|
80,829
|
|
|
92,792
|
|
Intangible asset
amortization
|
|
|
397
|
|
|
432
|
|
|
1,147
|
|
|
1,318
|
|
|
Total operating
expenses
|
|
|
42,902
|
|
|
46,259
|
|
|
127,489
|
|
|
135,560
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from
operations
|
|
|
6,233
|
|
|
(4,923)
|
|
|
12,588
|
|
|
(14,753)
|
|
Other
income
|
|
|
|
1,030
|
|
|
396
|
|
|
2,440
|
|
|
1,073
|
Income (loss) before
income taxes
|
|
|
7,263
|
|
|
(4,527)
|
|
|
15,028
|
|
|
(13,680)
|
|
Provision for income
taxes
|
|
|
92
|
|
|
23
|
|
|
180
|
|
|
49
|
Net income
(loss)
|
|
|
$
|
7,171
|
|
$
|
(4,550)
|
|
$
|
14,848
|
|
$
|
(13,729)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per
share, basic
|
|
$
|
0.14
|
|
$
|
(0.10)
|
|
$
|
0.30
|
|
$
|
(0.31)
|
Net income (loss) per
share, diluted
|
|
$
|
0.13
|
|
$
|
(0.10)
|
|
$
|
0.28
|
|
$
|
(0.31)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
shares outstanding, basic
|
|
52,389,012
|
|
|
44,885,287
|
|
|
50,321,640
|
|
|
44,669,201
|
Weighted average
shares outstanding, diluted
|
|
54,709,749
|
|
|
44,885,287
|
|
|
52,315,642
|
|
|
44,669,201
|
VANDA
PHARMACEUTICALS INC.
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
(in
thousands)
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30
2018 (1)
|
|
December 31
2017 (1)
|
|
ASSETS
|
|
|
|
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
|
$
|
60,778
|
|
$
|
33,627
|
|
|
Marketable
securities
|
|
|
|
|
179,801
|
|
|
109,786
|
|
|
Accounts receivable,
net
|
|
|
|
25,259
|
|
|
17,601
|
|
|
Inventory
|
|
|
|
|
|
887
|
|
|
840
|
|
|
Prepaid expenses and
other current assets
|
|
|
12,082
|
|
|
8,003
|
|
|
Total current
assets
|
|
|
|
|
278,807
|
|
|
169,857
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Property and
equipment, net
|
|
|
|
4,579
|
|
|
5,306
|
|
Intangible assets,
net
|
|
|
|
|
24,922
|
|
|
26,069
|
|
Non-current inventory
and other
|
|
|
|
3,629
|
|
|
4,193
|
|
|
Total
assets
|
|
|
|
$
|
311,937
|
|
$
|
205,425
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
|
|
Accounts payable and
accrued liabilities
|
|
$
|
19,046
|
|
$
|
20,335
|
|
|
Product revenue
allowances
|
|
|
|
27,196
|
|
|
23,028
|
|
|
Milestone obligations
under license agreements
|
|
|
|
|
-
|
|
|
27,000
|
|
|
Total current
liabilities
|
|
|
|
46,242
|
|
|
70,363
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other non-current
liabilities
|
|
|
|
4,278
|
|
|
3,675
|
|
|
Total
liabilities
|
|
|
|
|
50,520
|
|
|
74,038
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
|
|
|
|
|
|
Common
stock
|
|
|
|
|
52
|
|
|
45
|
|
|
Additional paid-in
capital
|
|
|
|
|
607,873
|
|
|
492,802
|
|
|
Accumulated other
comprehensive income (loss)
|
|
70
|
|
|
(34)
|
|
|
Accumulated
deficit
|
|
|
|
|
(346,578)
|
|
|
(361,426)
|
|
|
Total stockholders'
equity
|
|
|
|
261,417
|
|
|
131,387
|
|
|
Total liabilities and
stockholders' equity
|
|
$
|
311,937
|
|
$
|
205,425
|
|
|
|
|
(1)
|
With the adoption of
Accounting Standards Codification Subtopic 606, Revenue from
Contracts with Customers, on January 1, 2018, provision for
product returns is included in product revenue allowances and other
non-current liabilities in the current year. Provision for product
returns is included in accounts receivable, net in the prior year.
Please refer to footnote 2 in the quarterly report on Form 10-Q for
the quarter ended September 30, 2018, to be filed in the fourth
quarter of 2018, for more information.
|
VANDA
PHARMACEUTICALS INC.
|
Reconciliation of
GAAP to Non-GAAP Financial Information
|
(in thousands,
except for share and per share amounts)
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
Nine Months
Ended
|
|
|
|
|
|
September
30
|
|
September
30
|
|
September
30
|
|
September
30
|
|
|
|
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
Net income
(loss)
|
|
$
|
7,171
|
|
$
|
(4,550)
|
|
$
|
14,848
|
|
$
|
(13,729)
|
Adjustments:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based
compensation
|
|
|
2,872
|
|
|
2,771
|
|
|
8,744
|
|
|
7,683
|
|
Intangible asset
amortization
|
|
|
397
|
|
|
432
|
|
|
1,147
|
|
|
1,318
|
Non-GAAP Net income
(loss)
|
|
$
|
10,440
|
|
$
|
(1,347)
|
|
$
|
24,739
|
|
$
|
(4,728)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP Net income
(loss) per share, basic
|
|
$
|
0.20
|
|
$
|
(0.03)
|
|
$
|
0.49
|
|
$
|
(0.11)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
shares outstanding, basic
|
|
|
52,389,012
|
|
|
44,885,287
|
|
|
50,321,640
|
|
|
44,669,201
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses
|
|
$
|
42,902
|
|
$
|
46,259
|
|
$
|
127,489
|
|
$
|
135,560
|
Adjustments:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold
excluding amortization
|
|
(5,068)
|
|
|
(4,525)
|
|
|
(14,841)
|
|
|
(13,057)
|
|
Stock-based
compensation
|
|
|
(2,872)
|
|
|
(2,771)
|
|
|
(8,744)
|
|
|
(7,683)
|
|
Intangible asset
amortization
|
|
|
(397)
|
|
|
(432)
|
|
|
(1,147)
|
|
|
(1,318)
|
Non-GAAP Operating
expenses excluding
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods
sold
|
|
$
|
34,565
|
|
$
|
38,531
|
|
$
|
102,757
|
|
$
|
113,502
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
$
|
11,390
|
|
$
|
10,178
|
|
$
|
30,672
|
|
$
|
28,393
|
Adjustment:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based
compensation
|
|
|
(326)
|
|
|
(264)
|
|
|
(963)
|
|
|
(958)
|
Non-GAAP Research and
development
|
|
$
|
11,064
|
|
$
|
9,914
|
|
$
|
29,709
|
|
$
|
27,435
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and
administrative
|
|
$
|
26,047
|
|
$
|
31,124
|
|
$
|
80,829
|
|
$
|
92,792
|
Adjustment:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based
compensation
|
|
|
(2,546)
|
|
|
(2,507)
|
|
|
(7,781)
|
|
|
(6,725)
|
Non-GAAP Selling,
general and administrative
|
$
|
23,501
|
|
$
|
28,617
|
|
$
|
73,048
|
|
$
|
86,067
|
COMPANY CONTACT:
Jim Kelly
Executive Vice President & Chief Financial Officer
Vanda Pharmaceuticals Inc.
(202) 734-3428
jim.kelly@vandapharma.com
View original
content:http://www.prnewswire.com/news-releases/vanda-pharmaceuticals-reports-third-quarter-2018-financial-results-300745841.html
SOURCE Vanda Pharmaceuticals Inc.