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Vanda Pharmaceuticals Reports First Quarter 2016 Financial Results

WASHINGTON, May 4, 2016 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA), today announced financial and operational results for the first quarter ended March 31, 2016.

"Vanda made significant progress in the first quarter of 2016," said Mihael H. Polymeropoulos, M.D., Vanda's President and CEO. "We continued to grow our HETLIOZ and Fanapt franchises and we look forward to a number of important clinical development milestones in the coming months."

Key Highlights:

  • Total net product sales from HETLIOZ [®] and Fanapt [®] were $33.3 million during the first quarter of 2016, a 4% increase compared to $31.8 million in the fourth quarter of 2015 and a 50% increase compared to $22.2 million the first quarter of 2015.
  • In April 2016, Gian Piero Reverberi was named Senior Vice President, Chief Commercial Officer.

HETLIOZ [®] (tasimelteon)

  • HETLIOZ [®] net product sales grew to $16.2 million in the first quarter of 2016, a 7% increase compared to $15.1 million in the fourth quarter of 2015 and a 117% increase compared to $7.5 million in the first 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. A 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.
  • A Jet Lag Disorder Phase II proof of concept study is planned for the second half of 2016 leading to an expected Phase III program in 2017.

Fanapt [®] (iloperidone)

  • Fanapt [®] net product sales were $17.1 million for the first quarter of 2016, a 2% increase compared to $16.7 million in the fourth quarter of 2015 and a 16% increase compared to $14.7 million in the first quarter of 2015.
  • The U.S. Food and Drug Administration (FDA) review of the supplemental New Drug Application for Fanapt [®] that includes data for the maintenance treatment of schizophrenia in adults is ongoing. The FDA has set a PDUFA goal date of May 27, 2016.

Tradipitant

  • Enrollment began in the first quarter of 2016 for a tradipitant Phase II proof of concept study for the treatment of chronic pruritus in patients with atopic dermatitis.

Cash, cash equivalents and marketable securities (Cash) were $138.3 million as of March 31, 2016, representing a decrease to Cash of $4.9 million in the first quarter of 2016.

Non-GAAP Financial Results

For the first quarter of 2016, Non-GAAP net loss was $7.1 million, or $0.17 per share, compared to a Non-GAAP net loss of $4.1 million, or $0.10 per share, for the first 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 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 $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, May 4, 2016, at 4:30 PM ET. During the call, Vanda's management will discuss the first 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 42335557. A replay of the call will be available on Wednesday, May 4, 2016, beginning at 7:00 PM ET and will be accessible until Wednesday, May 11, 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 42335557.

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...


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