Vanda Pharmaceuticals, Inc. Reports Second Quarter 2016 Financial Results

WASHINGTON, July 27, 2016 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA), today announced financial and operational results for the second quarter ended June 30, 2016.

"Vanda's commercial business continues to demonstrate strong progress and growth," said Mihael H. Polymeropoulos, M.D., Vanda's President and CEO. "We look forward to our planned launch of HETLIOZ in Germany in the third quarter and the opportunity to bring an important therapy to Non-24 patients in Europe."

Key Highlights:

• Total net product sales from HETLIOZ^® and Fanapt^® were $36.0 million during the second quarter of 2016, an 8% increase compared to $33.3 million in the first quarter of 2016 and a 31% increase compared to $27.6 million in the second quarter of 2015.

HETLIOZ^® (tasimelteon)

• HETLIOZ^® net product sales grew to $17.5 million in the second quarter of 2016, an 8% increase compared to $16.2 million in the first quarter of 2016 and a 74% increase compared to $10.0 million in the second quarter of 2015.
• A HETLIOZ^® product launch in Germany is planned for the third quarter of 2016.
• Enrollment in the Smith-Magenis Syndrome (SMS) open label interventional study is ongoing. An SMS placebo controlled Phase III study is expected to begin in the second half of 2016.
• The Pediatric Non-24 pharmacokinetic study of the HETLIOZ^® liquid formulation is enrolling. A Phase III study is expected to begin in 2017.
• The screening of patients for a Jet Lag Disorder (JLD) Phase II proof of concept study began during the second quarter of 2016. Results from the JLD study are expected in the first half 2017.

Fanapt^® (iloperidone)

• Fanapt^® net product sales were $18.6 million for the second quarter of 2016, a 9% increase compared to $17.1 million in the first quarter of 2016 and a 6% increase compared to $17.6 million in the second quarter of 2015.
• In May 2016, the U.S. Food and Drug Administration (FDA) approved Vanda's supplemental New Drug Application (sNDA) for Fanapt^®, modifying and expanding the prescribing information for the use of Fanapt^® as a maintenance treatment for schizophrenia in adults. The FDA granted three years of marketing exclusivity for the changes related to the approval of the sNDA.
• A review of the Marketing Authorization Application for oral Fanaptum^® tablets by the European Medicines Agency (EMA) for the treatment of schizophrenia in adults is ongoing. An opinion by the EMA's Committee for Medicinal Products for Human Use (CHMP) is expected in the first quarter of 2017.

Tradipitant

• Enrollment in a tradipitant Phase II proof of concept study for the treatment of chronic pruritus in patients with atopic dermatitis is ongoing. Results are expected in the first half of 2017.
• A tradipitant Phase II proof of concept study for the treatment of gastroparesis is expected to begin enrolling patients in the fourth quarter of 2016. Results are expected in the second half of 2017.

Cash, cash equivalents and marketable securities (Cash) were $136.0 million as of June 30, 2016, representing a decrease to Cash of $2.3 million in the second quarter of 2016.

Non-GAAP Financial Results

For the second quarter of 2016, Non-GAAP net income was $0.4 million, compared to a Non-GAAP net loss of $0.4 million, for the second 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 with an update to stock-based compensation guidance and expects to achieve the following financial objectives in 2016:

• Combined net product sales from both HETLIOZ^® and Fanapt^® of between $143 and $153 million.
• HETLIOZ^® net product sales of between $73 and $78 million and Fanapt^® net product sales of between $70 and $75 million.
• Non-GAAP Operating expenses, excluding Cost of goods sold, of between $125 and $135 million.
• Non-GAAP Operating expenses excludes intangible asset amortization expense of $10.9 million and stock-based compensation of between $8 and $10 million. Prior guidance for stock-based compensation was between $9 and $11 million.
• Year end 2016 Cash is expected to be between $123 and $143 million.

Conference Call

Vanda has scheduled a conference call for today, Wednesday, July 27, 2016, at 4:30 PM ET.  During the call, Vanda's management will discuss the second 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 42972056.  A replay of the call will be available on Wednesday, July 27, 2016, beginning at 7:00 PM ET and will be accessible until Wednesday, August 3, 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 42972056.

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, 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 June 30, 2016, to be filed with the SEC in the third 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.

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