WASHINGTON, Nov. 2, 2016 /PRNewswire/ -- Vanda
Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA), today announced
financial and operational results for the third quarter ended
September 30, 2016.
"This quarter marks a significant milestone for Vanda, having
secured long-term exclusivity for Fanapt and demonstrated our
ability to grow our commercial assets and expand our pipeline of
products," said Mihael H.
Polymeropoulos, M.D., Vanda's President and CEO.
Key Highlights:
- Total net product sales from HETLIOZ® and
Fanapt® were $38.5 million
during the third quarter of 2016, a 7% increase compared to
$36.0 million in the second quarter
of 2016 and a 36% increase compared to $28.3
million in the third quarter of 2015.
- Cash, cash equivalents and marketable securities (Cash) were
$142.6 million as of September 30, 2016, representing an increase to
Cash of $6.6 million in the third
quarter of 2016.
HETLIOZ® (tasimelteon)
- HETLIOZ® net product sales grew to $18.7 million in the third quarter of 2016, a 7%
increase compared to $17.5 million in
the second quarter of 2016 and a 60% increase compared to
$11.7 million in the third quarter of
2015.
- In August 2016,
HETLIOZ® was made available in Germany, representing the first launch of
HETLIOZ® outside of the U.S.
- The pharmacokinetic study of the HETLIOZ® pediatric
formulation is enrolling.
- Enrollment in the Smith-Magenis Syndrome (SMS) open label
interventional study is ongoing. Enrollment in the SMS placebo
controlled clinical study began in the fourth quarter of 2016.
- The screening of patients for a Jet Lag Disorder clinical study
is ongoing. Results from the Jet Lag Disorder study are
expected in 2017.
Fanapt® (iloperidone)
- Fanapt® net product sales grew to $19.8 million in the third quarter of 2016, a 6%
increase compared to $18.6 million in
the second quarter of 2016 and a 19% increase compared to
$16.7 million in the third quarter of
2015.
- In August 2016, the Delaware District Court ruled that Roxane
Laboratories, Inc.'s (Roxane) proposed generic version of
Fanapt® infringed two of Vanda's patents and issued an
injunction barring Roxane from marketing its product until
November 2, 2027.
- In October 2016, Vanda settled
its Fanapt® patent litigation against Taro
Pharmaceuticals USA, Inc. and Taro
Pharmaceutical Industries, Ltd.
- An expansion of the Fanapt® U.S. field sales team is
now planned for the first quarter of 2017. An assessment of
new Fanapt® clinical opportunities is ongoing.
Tradipitant
- Enrollment in a tradipitant clinical study for the treatment of
chronic pruritus in patients with atopic dermatitis is ongoing.
Results are expected in 2017.
- A tradipitant clinical study for the treatment of gastroparesis
is expected to begin enrolling patients in the fourth quarter of
2016. Results are expected in 2017.
Non-GAAP Financial Results
For the third quarter of 2016, Non-GAAP net income was
$4.6 million, compared to a Non-GAAP
net loss of $4.5 million, for the
third quarter of 2015.
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."
2016 Financial Guidance
Vanda reiterates its prior 2016 financial guidance and expects
to achieve the following financial objectives in 2016:
Financial
Objectives
|
2016
Guidance
|
Combined net product
sales from both HETLIOZ® and
Fanapt®
|
$143 to $153
million
|
HETLIOZ®
net product sales
|
$73 to $78
million(2)
|
Fanapt®
net product sales
|
$70 to $75
million
|
Non-GAAP Operating
expenses, excluding Cost of goods sold(1)
|
$125 to $135
million(2)
|
Intangible asset
amortization
|
$10.9
million
|
Stock-based
compensation
|
$8 to $10
million
|
Year end 2016
Cash
|
$123 to $143
million(3)
|
|
(1) Non-GAAP
Operating expenses, excludes cost of goods sold, intangible asset
amortization and stock-based compensation.
|
(2) Results are
expected to be at the lower end of the guidance
range.
|
(3) Results are
expected to be at the higher end of the guidance
range.
|
Conference Call
Vanda has scheduled a conference call for today, Wednesday, November 2, 2016, at 4:30 PM ET. During the call, Vanda's
management will discuss the third quarter 2016 financial results
and other corporate activities. Investors can call
1-888-771-4371 (domestic) or 1-847-585-4405 (international) and use
passcode 43560411. A replay of the call will be available on
Wednesday, November 2, 2016,
beginning at 7:00 PM ET and will be
accessible until Wednesday, November 9,
2016, 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 43560411.
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 2016 Non-GAAP
Operating expenses, excluding Cost of goods sold, a forward-looking
Non-GAAP financial measure under the heading "2016 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 specialty pharmaceutical company focused on the
development and commercialization of novel 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 in the subheading to this release and
under "2016 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 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, 2015 and quarterly report on Form
10-Q for the quarter ended June 30,
2016, 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, 2016, to be filed with
the SEC in the fourth quarter of 2016. 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 (Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
Nine Months
Ended
|
|
September
30,
|
|
September
30,
|
|
September
30,
|
|
September
30,
|
($ in thousands,
except per share amounts)
|
2016
|
|
2015
|
|
2016
|
|
2015
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
HETLIOZ®product sales, net
|
$
|
18,715
|
|
$
|
11,682
|
|
$
|
52,376
|
|
$
|
29,159
|
|
Fanapt®product sales, net
|
|
19,767
|
|
|
16,662
|
|
|
55,397
|
|
|
48,917
|
|
|
Total
revenues
|
|
38,482
|
|
|
28,344
|
|
|
107,773
|
|
|
78,076
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods
sold
|
|
6,990
|
|
|
6,510
|
|
|
19,440
|
|
|
17,291
|
|
Research and
development
|
|
7,294
|
|
|
9,974
|
|
|
21,542
|
|
|
20,398
|
|
Selling, general and
administrative
|
|
21,908
|
|
|
18,458
|
|
|
75,880
|
|
|
55,650
|
|
Intangible asset
amortization
|
|
2,943
|
|
|
2,943
|
|
|
8,828
|
|
|
10,029
|
|
|
Total operating
expenses
|
|
39,135
|
|
|
37,885
|
|
|
125,690
|
|
|
103,368
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
|
(653)
|
|
|
(9,541)
|
|
|
(17,917)
|
|
|
(25,292)
|
|
Other
income
|
|
223
|
|
|
80
|
|
|
511
|
|
|
225
|
Net loss
|
$
|
(430)
|
|
$
|
(9,461)
|
|
$
|
(17,406)
|
|
$
|
(25,067)
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share,
basic and diluted
|
$
|
(0.01)
|
|
$
|
(0.22)
|
|
$
|
(0.40)
|
|
$
|
(0.60)
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
shares outstanding,
|
|
|
|
|
|
|
|
|
|
|
|
|
basic and
diluted
|
|
43,515,404
|
|
|
42,435,405
|
|
|
43,275,074
|
|
|
42,059,839
|
VANDA
PHARMACEUTICALS INC.
|
CONDENSED
CONSOLIDATED BALANCE SHEETS (Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
($ in
thousands)
|
|
|
|
|
September 30
2016
|
|
December 31
2015
|
ASSETS
|
|
|
|
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
|
$
|
32,765
|
|
$
|
50,843
|
|
|
Marketable
securities
|
|
|
|
|
109,814
|
|
|
92,337
|
|
|
Accounts receivable,
net
|
|
|
|
|
15,928
|
|
|
16,331
|
|
|
Inventory
|
|
|
|
|
|
865
|
|
|
1,294
|
|
|
Prepaid expenses and
other current assets
|
|
|
11,036
|
|
|
5,742
|
|
|
|
Total current
assets
|
|
|
|
|
170,408
|
|
|
166,547
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Property and
equipment, net
|
|
|
|
4,731
|
|
|
4,570
|
|
Intangible assets,
net
|
|
|
|
|
29,924
|
|
|
38,752
|
|
Non-current inventory
and other
|
|
|
|
3,380
|
|
|
3,181
|
|
|
|
Total
assets
|
|
|
|
$
|
208,443
|
|
$
|
213,050
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
|
|
Accounts payable and
accrued liabilities
|
|
$
|
17,572
|
|
$
|
15,767
|
|
|
Accrued government
and other rebates
|
|
|
33,109
|
|
|
35,550
|
|
|
|
Total current
liabilities
|
|
|
|
50,681
|
|
|
51,317
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Milestone obligation
under license agreement
|
|
25,000
|
|
|
25,000
|
|
|
Other non-current
liabilities
|
|
|
|
3,597
|
|
|
3,706
|
|
|
|
Total
liabilities
|
|
|
|
|
79,278
|
|
|
80,023
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
|
|
|
|
|
|
Common
stock
|
|
|
|
|
44
|
|
|
43
|
|
|
Additional paid-in
capital
|
|
|
|
|
474,234
|
|
|
460,794
|
|
|
Accumulated other
comprehensive income
|
|
|
142
|
|
|
39
|
|
|
Accumulated
deficit
|
|
|
|
|
(345,255)
|
|
|
(327,849)
|
|
|
|
Total stockholders'
equity
|
|
|
|
129,165
|
|
|
133,027
|
|
|
|
Total liabilities and
stockholders' equity
|
|
$
|
208,443
|
|
$
|
213,050
|
VANDA
PHARMACEUTICALS INC.
|
Reconciliation of
GAAP to Non-GAAP Financial Information (Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
Nine Months
Ended
|
|
|
|
|
September
30,
|
|
September
30,
|
|
September
30,
|
|
September
30,
|
(in thousands,
except for share and per share amounts)
|
2016
|
|
2015
|
|
2016
|
|
2015
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
$
|
(430)
|
|
$
|
(9,461)
|
|
$
|
(17,406)
|
|
$
|
(25,067)
|
Adjustments:
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based
compensation
|
|
2,100
|
|
|
2,061
|
|
|
6,440
|
|
|
6,074
|
Intangible asset
amortization
|
|
2,943
|
|
|
2,943
|
|
|
8,828
|
|
|
10,029
|
Non-GAAP Net income
(loss)
|
$
|
4,613
|
|
$
|
(4,457)
|
|
$
|
(2,138)
|
|
$
|
(8,964)
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP Net income
(loss) per share, basic
|
$
|
0.11
|
|
$
|
(0.11)
|
|
$
|
(0.05)
|
|
$
|
(0.21)
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
shares outstanding, basic
|
|
43,515,404
|
|
|
42,435,405
|
|
|
43,275,074
|
|
|
42,059,839
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses
|
$
|
39,135
|
|
$
|
37,885
|
|
$
|
125,690
|
|
$
|
103,368
|
Adjustments:
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods
sold
|
|
(6,990)
|
|
|
(6,510)
|
|
|
(19,440)
|
|
|
(17,291)
|
Stock-based
compensation
|
|
(2,100)
|
|
|
(2,061)
|
|
|
(6,440)
|
|
|
(6,074)
|
Intangible asset
amortization
|
|
(2,943)
|
|
|
(2,943)
|
|
|
(8,828)
|
|
|
(10,029)
|
Non-GAAP Operating
expenses
|
|
|
|
|
|
|
|
|
|
|
|
excluding Cost of goods
sold
|
$
|
27,102
|
|
$
|
26,371
|
|
$
|
90,982
|
|
$
|
69,974
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
$
|
7,294
|
|
$
|
9,974
|
|
$
|
21,542
|
|
$
|
20,398
|
Adjustment:
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based
compensation
|
|
(539)
|
|
|
(516)
|
|
|
(1,552)
|
|
|
(1,743)
|
Non-GAAP Research and
development
|
$
|
6,755
|
|
$
|
9,458
|
|
$
|
19,990
|
|
$
|
18,655
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and
administrative
|
$
|
21,908
|
|
$
|
18,458
|
|
$
|
75,880
|
|
$
|
55,650
|
Adjustment:
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based
compensation
|
|
(1,561)
|
|
|
(1,545)
|
|
|
(4,888)
|
|
|
(4,331)
|
Non-GAAP Selling,
general and administrative
|
$
|
20,347
|
|
$
|
16,913
|
|
$
|
70,992
|
|
$
|
51,319
|
COMPANY CONTACT:
Jim Kelly
Senior Vice President & Chief Financial Officer
Vanda Pharmaceuticals Inc.
(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-third-quarter-2016-financial-results-300356088.html
SOURCE Vanda Pharmaceuticals Inc.