Total net product sales were $47.4 million in the second quarter of 2018
- Total net product sales were $47.4 million in the second quarter of 2018
- Hetlioz® net product sales grew to $28.0 million in the second quarter of 2018
- Fanapt® net product sales grew to $19.3 million in the second quarter of 2018
- Vanda reiterates 2018 net product sales guidance of $180 million to $200 million
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 Full Year 2018
Guidance
Financial Objectives
--------------------
Combined net product
sales from $180 to $200 million
both HETLIOZ(R) and
Fanapt(R)
-------------------
HETLIOZ(R) net
product sales $108 to $118 million
---
Fanapt(R) net
product sales $72 to $82 million
-------------- ------------------
Non-GAAP Operating
expenses, $153 to $163 million
excluding Cost of
goods sold(1) 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(R)product
sales, net $28,045 $22,507 $53,468 $42,689
Fanapt(R)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 December 31
2018 (1) 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
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SOURCE Vanda Pharmaceuticals Inc.
Company Codes: NASDAQ-NMS:VNDA
