WASHINGTON, Nov. 7, 2017 /PRNewswire/ -- Vanda
Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA) today announced
financial and operational results for the third quarter ended
September 30, 2017.
"During the third quarter of 2017, Vanda demonstrated the
importance of the diverse set of ongoing initiatives to advance our
growth strategy," said Mihael H.
Polymeropoulos, M.D., Vanda's President and CEO. "The
tradipitant results in atopic dermatitis, early trends from the
HETLIOZ to psychiatrists initiative and the resolution of the
HETLIOZ pricing negotiation in Germany, all represent significant potential
drivers of growth."
Key Highlights:
- Total net product sales from HETLIOZ® and
Fanapt® were $41.3 million
in the third quarter of 2017, a 2% decrease compared to
$42.1 million in the second quarter
of 2017 and a 7% increase compared to $38.5
million in the third quarter of 2016.
HETLIOZ® (tasimelteon)
- HETLIOZ® net product sales were $22.3 million in the third quarter of 2017, a 1%
decrease compared to $22.5 million in
the second quarter of 2017 and a 19% increase compared to
$18.7 million in the third quarter of
2016.
- As of October 2017, the full
Fanapt® U.S. field force is promoting
HETLIOZ® to psychiatrists for their patients with
Non-24-Hour Sleep-Wake Disorder. Early results are encouraging and
Vanda believes this initiative has the potential to increase the
HETLIOZ® rate of growth in 2018.
- In October 2017, Vanda reached a
pricing agreement for HETLIOZ® with the German National
Association of Statutory Health Insurance Funds after an
Arbitration Board decision. Vanda plans to submit pricing and
reimbursement dossiers for HETLIOZ® in both France and Italy in the first half of 2018.
Fanapt® (iloperidone)
- Fanapt® net product sales were $19.1 million in the third quarter of 2017, a 3%
decrease compared to $19.5 million in
the second quarter of 2017 and a 4% decrease compared to
$19.8 million in the third quarter of
2016.
- Fanapt® prescriptions, as reported by QuintilesIMS
Incorporated, were 27,797 in the third quarter of 2017, a 2%
decline compared to the second quarter of 2017.
- The Federal Circuit Court of Appeals has scheduled oral
arguments on December 5, 2017 for the
appeal by West-Ward Pharmaceutical's (West-Ward) of the
Delaware District Court's decision
that West-Ward's ANDA product infringes Vanda's U.S. Patent No.
8,586,610 (the '610 Patent). The Delaware District Court issued an injunction
barring West-Ward from marketing its product until the expiration
of the '610 Patent on November 2,
2027.
Research and Development
Tradipitant
- In September 2017, results were
announced from a Phase II clinical study of tradipitant for
patients with atopic dermatitis, which showed significant
improvements in itch and disease severity. These results were
presented at the 9th World Congress of Itch in
October 2017.
- Vanda expects to hold an end of Phase II meeting with the U.S.
Food and Drug Administration (FDA) in the first quarter of 2018 to
discuss the tradipitant for atopic dermatitis clinical study. A
tradipitant for atopic dermatitis Phase III clinical study is
expected to begin in the first half of 2018.
- A tradipitant clinical study for the treatment of gastroparesis
is ongoing. Results are expected in mid 2018.
HETLIOZ®
- Results from the study of HETLIOZ® for the treatment
of jet lag disorder after transmeridian travel (2102) are expected
in the fourth quarter of 2017.
- An 8-hour phase advance, simulated jet lag disorder study
(3107) was initiated in October 2017
and is expected to be fully enrolled by the end of 2017. Results
are expected in the first quarter of 2018.
- A pharmacokinetic study of the HETLIOZ® pediatric
formulation is near completion. The study is expected to be fully
enrolled by the end of 2017.
- Enrollment in the Smith-Magenis Syndrome clinical study is
ongoing. Results are expected in 2018.
VTR-297 (histone deactetylase (HDAC) inhibitor)
- The FDA has accepted an Investigational New Drug application
for VTR-297, a small molecule HDAC inhibitor, and has provided
authorization to proceed with the treatment of patients with
relapsed and/or refractory hematologic malignancies.
- A VTR-297 Phase I study (1101) is expected to start in the
first half of 2018. The 1101 study is a dose escalation trial to
evaluate drug safety, tolerability and determine a recommended
clinical treatment regimen and dose.
Cash, cash equivalents and marketable securities (Cash) were
$139.9 million as of September 30, 2017, representing an increase to
Cash of $2.8 million during the third
quarter of 2017.
Non-GAAP Financial Results
For the third quarter of 2017, Non-GAAP net loss was
$1.3 million, or $0.03 per share, compared to a Non-GAAP net
income of $4.6 million, or
$0.11 per share, for the third
quarter of 2016.
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."
2017 Financial Guidance
Vanda is updating its 2017 financial guidance and expects to
achieve the following financial objectives in 2017:
Fourth Quarter
2017 Financial
Objectives
|
Fourth Quarter
2017 Guidance
|
|
Combined net product
sales from both HETLIOZ® and
Fanapt®
|
$42 to $48
million
|
|
HETLIOZ®
net product sales
|
$24 to $27
million
|
|
Fanapt®
net product sales
|
$18 to $21
million
|
|
|
|
|
Full Year
2017 Financial
Objectives
|
Revised Full Year
2017
Guidance
|
Prior Full Year
2017
Guidance
|
Combined net product
sales from both HETLIOZ® and
Fanapt®
|
$163 to $169
million
|
$165 to $175
million
|
HETLIOZ®
net product sales
|
$89 to $92
million
|
$88 to $93
million
|
Fanapt®
net product sales
|
$74 to $77
million
|
$77 to $82
million
|
Non-GAAP Operating
expenses, excluding Cost of goods sold(1)
|
$150 to $157
million
|
$162 to $172
million
|
Intangible asset
amortization
|
$1.7
million
|
$1.7
million
|
Stock-based
compensation
|
$9 to $12
million
|
$9 to $12
million
|
Year-end 2017
Cash
|
$131 to $141
million
|
$121 to $141
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, Tuesday, November 7, 2017, at 4:30 PM ET. During the call, Vanda's
management will discuss the third quarter 2017 financial results
and other corporate activities. Investors can call 1-888-771-4371
(domestic) or 1-847-585-4405 (international) and use passcode
45886211. A replay of the call will be available on Tuesday, November 7, 2017, beginning at
7:00 PM ET and will be accessible
until Tuesday, November 14, 2017, 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 45886211.
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 2017 Non-GAAP
Operating expenses, excluding Cost of goods sold, a forward-looking
Non-GAAP financial measure under the heading "2017 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 "2017 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 atopic
dermatitis, 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,
2016 and quarterly report on Form 10-Q for the fiscal
quarter ended June 30, 2017, 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 fiscal quarter
ended September 30, 2017, to be filed
with the SEC in the fourth quarter of 2017. 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
|
|
|
|
|
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
HETLIOZ®product sales, net
|
|
|
$
|
22,279
|
|
$
|
18,715
|
|
$
|
64,968
|
|
$
|
52,376
|
|
Fanapt®product sales, net
|
|
|
|
19,057
|
|
|
19,767
|
|
|
55,839
|
|
|
55,397
|
|
|
Total
revenues
|
|
|
|
|
41,336
|
|
|
38,482
|
|
|
120,807
|
|
|
107,773
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold
excluding amortization
|
|
|
4,525
|
|
|
6,990
|
|
|
13,057
|
|
|
19,440
|
|
Research and
development
|
|
|
|
10,178
|
|
|
7,294
|
|
|
28,393
|
|
|
21,542
|
|
Selling, general and
administrative
|
|
|
|
31,124
|
|
|
21,908
|
|
|
92,792
|
|
|
75,880
|
|
Intangible asset
amortization
|
|
|
|
432
|
|
|
2,943
|
|
|
1,318
|
|
|
8,828
|
|
|
Total operating
expenses
|
|
|
|
46,259
|
|
|
39,135
|
|
|
135,560
|
|
|
125,690
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
|
|
|
|
(4,923)
|
|
|
(653)
|
|
|
(14,753)
|
|
|
(17,917)
|
|
Other
income
|
|
|
|
|
396
|
|
|
223
|
|
|
1,073
|
|
|
511
|
Loss before income
taxes
|
|
|
|
|
(4,527)
|
|
|
(430)
|
|
|
(13,680)
|
|
|
(17,406)
|
|
Provision for income
taxes
|
|
|
|
23
|
|
|
-
|
|
|
49
|
|
|
-
|
Net loss
|
|
|
|
$
|
(4,550)
|
|
$
|
(430)
|
|
$
|
(13,729)
|
|
$
|
(17,406)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share,
basic and diluted
|
|
|
$
|
(0.10)
|
|
$
|
(0.01)
|
|
$
|
(0.31)
|
|
$
|
(0.40)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
shares outstanding, basic and diluted
|
|
44,885,287
|
|
|
43,515,404
|
|
|
44,669,201
|
|
|
43,275,074
|
VANDA
PHARMACEUTICALS INC.
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
(in
thousands)
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30
2017
|
|
December 31
2016
|
|
ASSETS
|
|
|
|
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
|
|
|
$
|
22,586
|
|
$
|
40,426
|
|
|
Marketable
securities
|
|
|
|
|
|
117,295
|
|
|
100,914
|
|
|
Accounts receivable,
net
|
|
|
|
|
|
18,179
|
|
|
20,268
|
|
|
Inventory
|
|
|
|
|
|
921
|
|
|
779
|
|
|
Prepaid expenses and
other current assets
|
|
|
|
|
|
10,738
|
|
|
11,788
|
|
|
|
Total current
assets
|
|
|
|
|
|
169,719
|
|
|
174,175
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Property and
equipment, net
|
|
|
|
|
|
5,448
|
|
|
5,015
|
|
Intangible assets,
net
|
|
|
|
|
|
26,501
|
|
|
27,819
|
|
Non-current inventory
and other
|
|
|
|
|
|
4,038
|
|
|
3,365
|
|
|
|
Total
assets
|
|
|
|
|
$
|
205,706
|
|
$
|
210,374
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable and
accrued liabilities
|
|
|
|
|
$
|
18,921
|
|
$
|
16,196
|
|
|
Accrued government
and other rebates
|
|
|
|
|
|
25,615
|
|
|
34,124
|
|
|
Milestone obligations
under license agreements
|
|
|
|
|
|
27,000
|
|
|
-
|
|
|
|
Total current
liabilities
|
|
|
|
|
|
71,536
|
|
|
50,320
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Milestone obligation
under license agreement
|
|
|
|
|
|
-
|
|
|
25,000
|
|
|
Other non-current
liabilities
|
|
|
|
|
|
3,701
|
|
|
3,724
|
|
|
|
Total
liabilities
|
|
|
|
|
|
75,237
|
|
|
79,044
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
|
|
|
|
|
|
|
Common
stock
|
|
|
|
|
|
45
|
|
|
44
|
|
|
Additional paid-in
capital
|
|
|
|
|
|
489,939
|
|
|
477,087
|
|
|
Accumulated other
comprehensive income
|
|
|
|
|
|
73
|
|
|
58
|
|
|
Accumulated
deficit
|
|
|
|
|
|
(359,588)
|
|
|
(345,859)
|
|
|
|
Total stockholders'
equity
|
|
|
|
|
|
130,469
|
|
|
131,330
|
|
|
|
Total liabilities and
stockholders' equity
|
|
|
|
|
$
|
205,706
|
|
$
|
210,374
|
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
|
|
|
|
|
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
Net loss
|
|
$
|
(4,550)
|
|
$
|
(430)
|
|
$
|
(13,729)
|
|
$
|
(17,406)
|
Adjustments:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based
compensation
|
|
|
2,771
|
|
|
2,100
|
|
|
7,683
|
|
|
6,440
|
|
Intangible asset
amortization
|
|
|
432
|
|
|
2,943
|
|
|
1,318
|
|
|
8,828
|
Non-GAAP Net income
(loss)
|
|
$
|
(1,347)
|
|
$
|
4,613
|
|
$
|
(4,728)
|
|
$
|
(2,138)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP Net income
(loss) per share, basic
|
|
$
|
(0.03)
|
|
$
|
0.11
|
|
$
|
(0.11)
|
|
$
|
(0.05)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
shares outstanding, basic
|
|
|
44,885,287
|
|
|
43,515,404
|
|
|
44,669,201
|
|
|
43,275,074
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses
|
|
$
|
46,259
|
|
$
|
39,135
|
|
$
|
135,560
|
|
$
|
125,690
|
Adjustments:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold
excluding amortization
|
|
|
(4,525)
|
|
|
(6,990)
|
|
|
(13,057)
|
|
|
(19,440)
|
|
Stock-based
compensation
|
|
|
(2,771)
|
|
|
(2,100)
|
|
|
(7,683)
|
|
|
(6,440)
|
|
Intangible asset
amortization
|
|
|
(432)
|
|
|
(2,943)
|
|
|
(1,318)
|
|
|
(8,828)
|
Non-GAAP Operating
expenses excluding
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods
sold
|
|
$
|
38,531
|
|
$
|
27,102
|
|
$
|
113,502
|
|
$
|
90,982
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
$
|
10,178
|
|
$
|
7,294
|
|
$
|
28,393
|
|
$
|
21,542
|
Adjustment:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based
compensation
|
|
|
(264)
|
|
|
(539)
|
|
|
(958)
|
|
|
(1,552)
|
Non-GAAP Research and
development
|
|
$
|
9,914
|
|
$
|
6,755
|
|
$
|
27,435
|
|
$
|
19,990
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and
administrative
|
|
$
|
31,124
|
|
$
|
21,908
|
|
$
|
92,792
|
|
$
|
75,880
|
Adjustment:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based
compensation
|
|
|
(2,507)
|
|
|
(1,561)
|
|
|
(6,725)
|
|
|
(4,888)
|
Non-GAAP Selling,
general and administrative
|
|
$
|
28,617
|
|
$
|
20,347
|
|
$
|
86,067
|
|
$
|
70,992
|
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-2017-financial-results-300551228.html
SOURCE Vanda Pharmaceuticals Inc.