WASHINGTON, May 2, 2018 /PRNewswire/ -- Vanda
Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced
financial and operational results for the first quarter ended
March 31, 2018.
"We are pleased with the progress made in 2018 with the
continued growth of our HETLIOZ business and the successful defense
of our U.S. Fanapt franchise," said Mihael
H. Polymeropoulos, M.D., Vanda's President and CEO. "Our
research and development programs are progressing including life
cycle management of commercialized products and the advancement of
our late stage clinical pipeline."
Key Highlights:
- Total net product sales from HETLIOZ® and
Fanapt® were $43.6 million
during the first quarter of 2018, a 2% decrease compared to
$44.3 million in the fourth quarter
of 2017 and a 17% increase compared to $37.4
million in the first quarter of 2017.
- In March 2018, Vanda completed a
public offering of its common stock that resulted in net proceeds
of $100.9 million.
HETLIOZ® (tasimelteon)
- HETLIOZ® net product sales were $25.4 million in the first quarter of 2018, a 2%
increase compared to $25.0 million in
the fourth quarter of 2017 and a 26% increase compared to
$20.2 million in the first quarter of
2017.
- In April 2018, Vanda filed a
lawsuit against Teva Pharmaceuticals USA, Inc. for infringement of
HETLIOZ® patents by submitting to the U.S. Food and Drug
Administration (the FDA) an Abbreviated New Drug Application for a
generic version of HETLIOZ® prior to the expiration of
the latest to expire of Vanda's HELTIOZ® patents in
2034.
Fanapt® (iloperidone)
- Fanapt® net product sales were $18.2 million in the first quarter of 2018, a 6%
decrease compared to $19.3 million in
the fourth quarter of 2017 and a 5% increase compared to
$17.2 million in the first quarter of
2017.
- Fanapt® prescriptions, as reported by IQVIA, were
27,372 in the first quarter of 2018, a 3% decrease compared to the
fourth quarter of 2017.
- In April 2018, the U.S. Court of
Appeals for the Federal Circuit affirmed the U.S. District Court
for the District of Delaware's
decision that West Ward Pharmaceuticals, a subsidiary of Hikma
Pharmaceuticals, infringed Vanda's U.S. Patent number 8,586,610
(the '610 Patent) for Fanapt®. The '610 Patent is set to
expire November 2, 2027.
Research and Development
Tradipitant
- Vanda held an end of Phase II meeting with the FDA in
April 2018 to discuss the clinical
and regulatory path forward for tradipitant as a treatment for
chronic pruritus in atopic dermatitis. A Phase III clinical study
is expected to begin in the second quarter of 2018.
- A tradipitant clinical study for the treatment of gastroparesis
is ongoing. Results are expected by the end of 2018.
HETLIOZ®
- Results from the JET8 Phase III clinical study to treat jet lag
disorder in an 8 hour phase advance (3107) showed significant and
clinically meaningful effects of HETLIOZ® 20mg on the
primary endpoint of the study as well as multiple secondary
endpoints in the treatment of jet lag disorder. Vanda intends to
seek U.S. marketing approval for the use of HETLIOZ® in
the treatment of jet lag disorder.
- A pharmacokinetic study of the HETLIOZ® pediatric
liquid formulation is now complete.
- Enrollment in the Smith-Magenis Syndrome clinical study 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 start in the second half of 2018.
Cash, cash equivalents and marketable securities (Cash) were
$248.8 million as of March 31, 2018, representing an increase to Cash
of $105.4 million during the first
quarter of 2018.
Non-GAAP Financial Results
Non-GAAP net income was $6.6
million for the first quarter of 2018, or $0.14 per share, compared to a Non-GAAP net loss
of $4.9 million, or $0.11 per share, for the first 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" for more
detailed information regarding Non-GAAP financial information.
2018 Financial Guidance
Vanda reiterates its prior 2018 financial guidance, updates its
year-end 2018 Cash(1) 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(2)
|
$163 to $173
million
|
Intangible asset
amortization
|
$1.7
million
|
Stock-based
compensation
|
$11 to $15
million
|
Year-end 2018
Cash(1)
|
$215 to $225
million
as compared to prior
guidance of
$115 to $125 million
|
|
|
(1)
|
Year-end 2018 Cash
includes the expected payment of a $25 million milestone obligation
based on cumulative HETLIOZ® net product sales and the
net proceeds of $100.9 million from the March 2018 public
offering.
|
(2)
|
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, May 2, 2018, at 4:30 PM ET. During the call, Vanda's
management will discuss the first 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
46823596. A replay of the call will be available on Wednesday, May 2, 2018, beginning at 7:00 PM ET and will be accessible until
Wednesday, May 9, 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 46823596.
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, 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, which is 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 March 31, 2018, to be filed with the SEC in the
second 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
|
|
|
|
|
|
|
|
March
31
|
|
March
31
|
|
|
|
|
|
|
|
2018
|
|
2017
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
HETLIOZ®product sales, net
|
|
|
$
|
25,423
|
|
$
|
20,182
|
|
|
Fanapt®product sales, net
|
|
|
|
18,169
|
|
|
17,233
|
|
|
|
Total
revenues
|
|
|
|
|
43,592
|
|
|
37,415
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold
excluding amortization
|
|
|
4,560
|
|
|
4,003
|
|
|
Research and
development
|
|
|
|
9,416
|
|
|
10,567
|
|
|
Selling, general and
administrative
|
|
|
|
26,822
|
|
|
30,297
|
|
|
Intangible asset
amortization
|
|
|
|
352
|
|
|
454
|
|
|
|
Total operating
expenses
|
|
|
|
41,150
|
|
|
45,321
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from
operations
|
|
|
|
2,442
|
|
|
(7,906)
|
|
|
Other
income
|
|
|
|
|
622
|
|
|
280
|
|
Income (loss) before
income taxes
|
|
|
|
3,064
|
|
|
(7,626)
|
|
|
Provision (benefit)
for income taxes
|
|
|
|
(2)
|
|
|
19
|
|
Net income
(loss)
|
|
|
|
$
|
3,066
|
|
$
|
(7,645)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per
share, basic
|
|
|
$
|
0.07
|
|
$
|
(0.17)
|
|
Net income (loss) per
share, diluted
|
|
|
$
|
0.06
|
|
$
|
(0.17)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
shares outstanding, basic
|
|
|
46,336,430
|
|
|
44,398,359
|
|
Weighted average
shares outstanding, diluted
|
|
|
48,225,041
|
|
|
44,398,359
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
VANDA PHARMACEUTICALS INC.
CONDENSED
CONSOLIDATED BALANCE
SHEETS
|
|
|
|
|
|
(in
thousands)
|
|
|
|
|
|
|
|
|
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31
2018 (1)
|
|
December 31
2017 (1)
|
ASSETS
|
|
|
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
|
$
|
155,293
|
|
$
|
33,627
|
|
Marketable
securities
|
|
|
|
|
93,541
|
|
|
109,786
|
|
Accounts receivable,
net
|
|
|
|
23,314
|
|
|
17,601
|
|
Inventory
|
|
|
|
|
|
1,011
|
|
|
840
|
|
Prepaid expenses and
other current assets
|
|
|
9,276
|
|
|
8,003
|
|
|
Total current
assets
|
|
|
|
|
282,435
|
|
|
169,857
|
|
|
|
|
|
|
|
|
|
|
|
|
Property and
equipment, net
|
|
|
|
5,105
|
|
|
5,306
|
Intangible assets,
net
|
|
|
|
|
25,717
|
|
|
26,069
|
Non-current inventory
and other
|
|
|
|
4,058
|
|
|
4,193
|
|
|
Total
assets
|
|
|
|
$
|
317,315
|
|
$
|
205,425
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
|
Accounts payable and
accrued liabilities
|
|
$
|
17,242
|
|
$
|
20,335
|
|
Product revenue
allowances
|
|
|
|
27,713
|
|
|
23,028
|
|
Milestone obligations
under license agreements
|
|
|
|
|
27,000
|
|
|
27,000
|
|
|
Total current
liabilities
|
|
|
|
71,955
|
|
|
70,363
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other non-current
liabilities
|
|
|
|
4,216
|
|
|
3,675
|
|
|
Total
liabilities
|
|
|
|
|
76,171
|
|
|
74,038
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
|
|
|
|
|
Common
stock
|
|
|
|
|
52
|
|
|
45
|
|
Additional paid-in
capital
|
|
|
|
|
599,480
|
|
|
492,802
|
|
Accumulated other
comprehensive loss
|
|
|
(28)
|
|
|
(34)
|
|
Accumulated
deficit
|
|
|
|
|
(358,360)
|
|
|
(361,426)
|
|
|
Total stockholders'
equity
|
|
|
|
241,144
|
|
|
131,387
|
|
|
Total liabilities and
stockholders' equity
|
|
$
|
317,315
|
|
$
|
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.
Refer to footnote 2 in the quarterly report on Form 10Q for the
quarter ending March 31, 2018.
|
VANDA
PHARMACEUTICALS INC.
|
Reconciliation of
GAAP to Non-GAAP Financial Information
|
(in thousands,
except for share and per share amounts)
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
|
|
|
|
|
|
March
31
|
|
March
31
|
|
|
|
|
|
|
|
2018
|
|
2017
|
|
Net income
(loss)
|
|
|
$
|
3,066
|
|
$
|
(7,645)
|
|
Adjustments:
|
|
|
|
|
|
|
|
|
|
Stock-based
compensation
|
|
|
|
3,151
|
|
|
2,256
|
|
|
Intangible asset
amortization
|
|
|
|
352
|
|
|
454
|
|
Non-GAAP Net income
(loss)
|
|
|
$
|
6,569
|
|
$
|
(4,935)
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP Net income
(loss) per share, basic
|
|
$
|
0.14
|
|
$
|
(0.11)
|
|
Non-GAAP Net income
(loss) per share, diluted
|
|
$
|
0.14
|
|
$
|
(0.11)
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
shares outstanding, basic
|
|
|
46,336,430
|
|
|
44,398,359
|
|
Weighted average
shares outstanding, diluted
|
|
|
48,225,041
|
|
|
44,398,359
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses
|
|
|
$
|
41,150
|
|
$
|
45,321
|
|
Adjustments:
|
|
|
|
|
|
|
|
|
|
Cost of goods sold
excluding amortization
|
|
|
(4,560)
|
|
|
(4,003)
|
|
|
Stock-based
compensation
|
|
|
|
(3,151)
|
|
|
(2,256)
|
|
|
Intangible asset
amortization
|
|
|
|
(352)
|
|
|
(454)
|
|
Non-GAAP Operating
expenses excluding
|
|
|
|
|
|
|
|
|
|
Cost of goods
sold
|
|
|
|
$
|
33,087
|
|
$
|
38,608
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
|
|
$
|
9,416
|
|
$
|
10,567
|
|
Adjustment:
|
|
|
|
|
|
|
|
|
|
|
Stock-based
compensation
|
|
|
|
(321)
|
|
|
(409)
|
|
Non-GAAP Research and
development
|
|
|
$
|
9,095
|
|
$
|
10,158
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and
administrative
|
|
|
$
|
26,822
|
|
$
|
30,297
|
|
Adjustment:
|
|
|
|
|
|
|
|
|
|
|
Stock-based
compensation
|
|
|
|
(2,830)
|
|
|
(1,847)
|
|
Non-GAAP Selling,
general and administrative
|
|
$
|
23,992
|
|
$
|
28,450
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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-first-quarter-2018-financial-results-300641433.html
SOURCE Vanda Pharmaceuticals Inc.