WASHINGTON, Aug. 1, 2018 /PRNewswire/ -- Vanda
Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced
financial and operational results for the second quarter ended
June 30, 2018.
"We are excited with the year to date HETLIOZ sales performance,
which demonstrates continued strength, and our HETLIOZ life cycle
management program, which positions the product well for additional
future growth," said Mihael H.
Polymeropoulos, M.D., Vanda's President and CEO. "We are
focused on our upcoming clinical milestones from the tradipitant
gastroparesis study and the HETLIOZ Smith-Magenis Syndrome
study."
Key Highlights:
- Total net product sales from HETLIOZ® and
Fanapt® were $47.4 million
during the second quarter of 2018, a 9% increase compared to
$43.6 million in the first quarter of
2018 and a 13% increase compared to $42.1
million in the second quarter of 2017.
HETLIOZ® (tasimelteon)
- HETLIOZ® net product sales were $28.0 million in the second quarter of 2018, a
10% increase compared to $25.4
million in the first quarter of 2018 and a 25% increase
compared to $22.5 million in the
second quarter of 2017.
Fanapt® (iloperidone)
- Fanapt® net product sales were $19.3 million in the second quarter of 2018, a 6%
increase compared to $18.2 million in
the first quarter of 2018 and a 1% decrease compared to
$19.5 million in the second quarter
of 2017.
Research and Development
HETLIOZ®
- Results from the JET study, a 3-night transatlantic Phase II
study of the effects of tasimelteon on jet lag disorder showed
effectiveness in treating travelers who flew from the US to
the UK. Vanda expects to submit a supplemental New Drug
Application to the U.S. Food and Drug Administration for
HETLIOZ® for the treatment of jet lag disorder by the
end of 2018.
- Enrollment in the Smith-Magenis Syndrome clinical study is
ongoing. Results are expected by the end of 2018.
Tradipitant
- In June 2018, Vanda initiated
EPIONE, a Phase III study of tradipitant for chronic pruritus in
atopic dermatitis.
- A tradipitant clinical study for the treatment of gastroparesis
is ongoing. Results are expected by the end of 2018.
VTR-297 (histone deacetylase (HDAC) inhibitor)
- A VTR-297 Phase I study (1101) in patients with hematologic
malignancies is expected to begin by the end of 2018.
Cash, cash equivalents and marketable securities (Cash) were
$231.2 million as of June 30, 2018. During the second quarter of
2018, Cash decreased by $17.6 million
and included a $25.0 million
milestone payment based on cumulative HETLIOZ® net
product sales.
Non-GAAP Financial Results
For the second quarter of 2018, Non-GAAP net income was
$7.7 million, or $0.15 per share, compared to Non-GAAP net income
of $1.6 million, or $0.03 per share, for the second 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 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(1)
|
$153 to $163
million
as compared to prior
guidance of $163 to $173
million
|
Intangible asset
amortization
|
$1.7
million
|
Stock-based
compensation
|
$11 to $15
million
|
Year-end 2018
Cash
|
$225 to $235
million
as compared to prior
guidance of $215 to $225
million
|
(1) Non-GAAP Operating expenses, excludes Cost of goods sold,
intangible asset amortization and stock-based compensation.
Conference Call
Vanda has scheduled a conference call for today, Wednesday, August 1, 2018, at 4:30 PM ET. During the call, Vanda's
management will discuss the second quarter 2018 financial results
and other corporate activities. Investors can call 1-800-708-4539
(domestic) or 1-847-619-6396 (international) and use passcode
47289344. A replay of the call will be available on Wednesday, August 1, 2018, beginning at
7:00 PM ET and will be accessible
until Wednesday, August 8, 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 47289344.
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. through the
HETLIOZ® to Psychiatrists Initiative, among other means,
Vanda's ability to complete the clinical development and obtain
regulatory approval of tradipitant for the treatment of chronic
pruritus in 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 March 31, 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 June 30, 2018, to be filed with the SEC in the
third 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
|
|
Six Months
Ended
|
|
|
|
|
|
|
June
30
|
|
June
30
|
|
June
30
|
|
June
30
|
|
|
|
|
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
HETLIOZ®product sales, net
|
|
|
$
|
28,045
|
|
$
|
22,507
|
|
$
|
53,468
|
|
$
|
42,689
|
|
Fanapt®product sales, net
|
|
|
|
19,305
|
|
|
19,549
|
|
|
37,474
|
|
|
36,782
|
|
|
Total
revenues
|
|
|
|
|
47,350
|
|
|
42,056
|
|
|
90,942
|
|
|
79,471
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold
excluding amortization
|
|
|
5,213
|
|
|
4,529
|
|
|
9,773
|
|
|
8,532
|
|
Research and
development
|
|
|
|
9,866
|
|
|
7,648
|
|
|
19,282
|
|
|
18,215
|
|
Selling, general and
administrative
|
|
|
|
27,960
|
|
|
31,371
|
|
|
54,782
|
|
|
61,668
|
|
Intangible asset
amortization
|
|
|
|
398
|
|
|
432
|
|
|
750
|
|
|
886
|
|
|
Total operating
expenses
|
|
|
|
43,437
|
|
|
43,980
|
|
|
84,587
|
|
|
89,301
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from
operations
|
|
|
|
3,913
|
|
|
(1,924)
|
|
|
6,355
|
|
|
(9,830)
|
|
Other
income
|
|
|
|
|
788
|
|
|
397
|
|
|
1,410
|
|
|
677
|
Income (loss) before
income taxes
|
|
|
|
4,701
|
|
|
(1,527)
|
|
|
7,765
|
|
|
(9,153)
|
|
Provision (benefit)
for income taxes
|
|
|
|
90
|
|
|
7
|
|
|
88
|
|
|
26
|
Net income
(loss)
|
|
|
|
$
|
4,611
|
|
$
|
(1,534)
|
|
$
|
7,677
|
|
$
|
(9,179)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per
share, basic
|
|
|
$
|
0.09
|
|
$
|
(0.03)
|
|
$
|
0.16
|
|
$
|
(0.21)
|
Net income (loss) per
share, diluted
|
|
|
$
|
0.09
|
|
$
|
(0.03)
|
|
$
|
0.15
|
|
$
|
(0.21)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
shares outstanding, basic
|
|
|
52,172,982
|
|
|
44,718,597
|
|
|
49,270,829
|
|
|
44,559,368
|
Weighted average
shares outstanding, diluted
|
|
|
53,945,640
|
|
|
44,718,597
|
|
|
51,101,464
|
|
|
44,559,368
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
VANDA
PHARMACEUTICALS INC.
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
|
|
|
|
(in
thousands)
|
|
|
|
|
|
|
|
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30
2018 (1)
|
|
December 31
2017 (1)
|
|
ASSETS
|
|
|
|
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
|
$
|
60,891
|
|
$
|
33,627
|
|
|
Marketable
securities
|
|
|
|
|
170,325
|
|
|
109,786
|
|
|
Accounts receivable,
net
|
|
|
|
24,855
|
|
|
17,601
|
|
|
Inventory
|
|
|
|
|
|
1,193
|
|
|
840
|
|
|
Prepaid expenses and
other current assets
|
|
|
11,838
|
|
|
8,003
|
|
|
|
Total current
assets
|
|
|
|
|
269,102
|
|
|
169,857
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Property and
equipment, net
|
|
|
|
4,800
|
|
|
5,306
|
|
Intangible assets,
net
|
|
|
|
|
25,319
|
|
|
26,069
|
|
Non-current inventory
and other
|
|
|
|
3,705
|
|
|
4,193
|
|
|
|
Total
assets
|
|
|
|
$
|
302,926
|
|
$
|
205,425
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
|
|
Accounts payable and
accrued liabilities
|
|
$
|
18,562
|
|
$
|
20,335
|
|
|
Product revenue
allowances
|
|
|
|
26,319
|
|
|
23,028
|
|
|
Milestone obligations
under license agreements
|
|
|
|
|
2,000
|
|
|
27,000
|
|
|
|
Total current
liabilities
|
|
|
|
46,881
|
|
|
70,363
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other non-current
liabilities
|
|
|
|
4,774
|
|
|
3,675
|
|
|
|
Total
liabilities
|
|
|
|
|
51,655
|
|
|
74,038
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
|
|
|
|
|
|
Common
stock
|
|
|
|
|
52
|
|
|
45
|
|
|
Additional paid-in
capital
|
|
|
|
|
604,889
|
|
|
492,802
|
|
|
Accumulated other
comprehensive income (loss)
|
|
79
|
|
|
(34)
|
|
|
Accumulated
deficit
|
|
|
|
|
(353,749)
|
|
|
(361,426)
|
|
|
|
Total stockholders'
equity
|
|
|
|
251,271
|
|
|
131,387
|
|
|
|
Total liabilities and
stockholders' equity
|
|
$
|
302,926
|
|
$
|
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 June 30, 2018, to be
filed with the SEC in the third 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
|
|
Six Months
Ended
|
|
|
|
|
|
|
June
30
|
|
June
30
|
|
June
30
|
|
June
30
|
|
|
|
|
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
Net income
(loss)
|
|
|
|
$
|
4,611
|
|
$
|
(1,534)
|
|
$
|
7,677
|
|
$
|
(9,179)
|
Adjustments:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based
compensation
|
|
|
|
2,721
|
|
|
2,656
|
|
|
5,872
|
|
|
4,912
|
|
Intangible asset
amortization
|
|
|
|
398
|
|
|
432
|
|
|
750
|
|
|
886
|
Non-GAAP Net income
(loss)
|
|
|
$
|
7,730
|
|
$
|
1,554
|
|
$
|
14,299
|
|
$
|
(3,381)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP Net income
(loss) per share, basic
|
|
$
|
0.15
|
|
$
|
0.03
|
|
$
|
0.29
|
|
$
|
(0.08)
|
Non-GAAP Net income
(loss) per share, diluted
|
|
$
|
0.14
|
|
$
|
0.03
|
|
$
|
0.28
|
|
$
|
(0.08)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
shares outstanding, basic
|
|
|
52,172,982
|
|
|
44,718,597
|
|
|
49,270,829
|
|
|
44,559,368
|
Weighted average
shares outstanding, diluted
|
|
|
53,945,640
|
|
|
44,718,597
|
|
|
51,101,464
|
|
|
44,559,368
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses
|
|
|
|
$
|
43,437
|
|
$
|
43,980
|
|
$
|
84,587
|
|
$
|
89,301
|
Adjustments:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold
excluding amortization
|
|
|
(5,213)
|
|
|
(4,529)
|
|
|
(9,773)
|
|
|
(8,532)
|
|
Stock-based
compensation
|
|
|
|
(2,721)
|
|
|
(2,656)
|
|
|
(5,872)
|
|
|
(4,912)
|
|
Intangible asset
amortization
|
|
|
|
(398)
|
|
|
(432)
|
|
|
(750)
|
|
|
(886)
|
Non-GAAP Operating
expenses excluding
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods
sold
|
|
|
|
$
|
35,105
|
|
$
|
36,363
|
|
$
|
68,192
|
|
$
|
74,971
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
|
|
$
|
9,866
|
|
$
|
7,648
|
|
$
|
19,282
|
|
$
|
18,215
|
Adjustment:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based
compensation
|
|
|
|
(316)
|
|
|
(285)
|
|
|
(637)
|
|
|
(694)
|
Non-GAAP Research and
development
|
|
|
$
|
9,550
|
|
$
|
7,363
|
|
$
|
18,645
|
|
$
|
17,521
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and
administrative
|
|
|
$
|
27,960
|
|
$
|
31,371
|
|
$
|
54,782
|
|
$
|
61,668
|
Adjustment:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based
compensation
|
|
|
|
(2,405)
|
|
|
(2,371)
|
|
|
(5,235)
|
|
|
(4,218)
|
Non-GAAP Selling,
general and administrative
|
|
$
|
25,555
|
|
$
|
29,000
|
|
$
|
49,547
|
|
$
|
57,450
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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-second-quarter-2018-financial-results-300690517.html
SOURCE Vanda Pharmaceuticals Inc.