The following excerpt is from the company's
Vanda affirms its full year net product sales guidance of between $100 million and $115 million
November 3, 2015 Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA), today announced financial and operational results for the third quarter ended September 30, 2015.
With another strong performance in Q3, Vanda is on target to achieve more than $100 million in net product sales for 2015, which represents a significant milestone in the history of the company, said Mihael H. Polymeropoulos, M.D., Vandas President and CEO. W e look forward to growing our HETLIOZ Non-24 franchise, stabilizing Fanapt revenue and pursuing exciting near-term opportunities, including Jet Lag Disorder.
net product sales grew to $11.7 million in the third quarter of 2015, a 17% increase compared to $10.0 million in the second quarter of 2015 and a 124% increase compared to $5.2 million reported in the third quarter of 2014.
A Phase III study of HETLIOZ
for the treatment of Jet Lag Disorder is expected to begin in the first quarter of 2016.
Preparations are ongoing for a 2016 European launch of HETLIOZ
for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24).
net product sales of $16.7 million during the third quarter of 2015 reflected a 5% decline as compared to net product sales of $17.6 million recorded in the second quarter of 2015 and a 1% decline compared to $16.9 million reported by Novartis for Fanapt
Since August 2015, five additional Fanapt
patents were listed in the U.S Food and Drug Administrations (FDA) Orange Book further expanding the method of use patent portfolio for Fanapt
which now includes nine method patents with expiry dates that range from 2025 to 2031.
In September 2015, the FDA accepted for review a supplemental New Drug Application for Fanapt
for the maintenance treatment of schizophrenia in adults. The FDA has set a PDUFA goal date in May 2016 to complete its review.
Vanda expects to file for European regulatory approval of oral Fanapt
in the fourth quarter of 2015.
Cash, cash equivalents and marketable securities were $144.3 million as of September 30, 2015.
Non-GAAP Financial Results
Vanda Non-GAAP total revenues for the third quarter of 2015 were $28.3 million, compared to Non-GAAP total revenues of $7.0 million for the third quarter of 2014.
For the third quarter of 2015, Non-GAAP net loss was $4.5 million, or $0.11 per share, compared with a Non-GAAP net loss of $7.2 million, or $0.21 per share, for the same period in 2014.
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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.
Vanda Affirms 2015 Financial Guidance
Vanda is affirming its 2015 financial guidance and expects to achieve the following financial objectives in 2015:
Combined net product sales from both HETLIOZ
of between $100 million and $115 million.
net product sales of between $40 million to $45 million.
net product sales of between $60 million to $70 million.
Non-GAAP Operating expenses, excluding cost of goods sold, of between $100 million and $110 million.
Non-GAAP Operating expenses also excludes:
Intangible asset amortization expense of $13.0 million.
Stock-based compensation of between $8.5 million and $10.5 million.
Full U.S. HETLIOZ
Prescribing Information can be found at:
Full U.S. Fanapt
Prescribing Information, including Boxed Warnings and Important Safety Information can be found at:
Vanda has scheduled a conference call for today, Tuesday, November 3, 2015, at 4:30 PM ET. During the call, Vandas management will discuss the third quarter 2015 financial results and other corporate activities. Investors can call 1-800-708-4539 (domestic) or 1-847-619-6396 (international) and use passcode 40977296. A replay of the call will be available beginning Tuesday, November 3, 2015 at 7:00 PM ET and will be accessible until Tuesday, November 10, 2015, 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 40977296.
The conference call will be broadcast simultaneously on Vandas website,
. Investors should click on the Investor Relations...