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Vanda Pharmaceuticals, Inc. (VNDA) Reports Second Quarter 2014 Results


8/7/2014 9:34:19 AM

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WASHINGTON, Aug. 7, 2014 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA), a biopharmaceutical company focused on the development and commercialization of products for the treatment of central nervous system disorders, today announced financial and operational results for the second quarter ended June 30, 2014.

"We are encouraged by the early positive reception of HETLIOZ by patients, physicians and payors. We look forward to more patients benefiting from HETLIOZ in the coming months and years," said Mihael Polymeropoulos MD, President and CEO of Vanda Pharmaceuticals.

Key Highlights:

  • As of August 6, 2014, over 420 new patient prescriptions have been written for  HETLIOZ®(tasimelteon) in the U.S.
  • In June 2014, Vanda announced that the European Medicines Agency (EMA) accepted for evaluation the Marketing Authorization Application for oral HETLIOZ® capsules for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24).
  • In July 2014, the U.S. Patent and Trademark Office (USPTO) issued a new method of use patent for HETLIOZ®  in the treatment of Non-24.

SECOND QUARTER 2014 REPORTED RESULTS

Total revenues for the second quarter of 2014 were $10.9 million, compared to $9.1 million for the first quarter of 2014 and $8.3 million for the second quarter of 2013.  Net product revenues related to U.S. sales of HETLIOZ® in the second quarter of 2014 were $1.6 million.  

Total operating expenses for the second quarter of 2014 were $32.5 million, compared to $35.7 million for the first quarter of 2014 and $11.7 million for the second quarter of 2013.  Vanda recorded a net loss of $21.6 million for the second quarter of 2014, compared to a net loss of $26.5 million for the first quarter of 2014 and $3.4 million for the second quarter of 2013.   

Cash, cash equivalents and marketable securities (Cash) were $63.6 million as of June 30, 2014.

Year to Date June 30, 2014 Key Financial Figures(1) (2)

 


Six Months Ended






June 30,


June 30,





($ in thousands, except per share amounts)

2014


2013


  Change ($)


Change (%)









Total revenues

$         20,005


$         16,387


$           3,618


22%

Research & development  expenses

10,777


14,211


(3,434)


(24%)

Selling, general & administrative expenses

56,032


9,413


46,619


495%

Non-cash stock-based compensation (3)

2,836


2,432


404


17%

Net loss

(48,108)


(7,902)


(40,206)


(509%)









Diluted net loss per share

$            (1.42)


$            (0.28)


$            (1.14)


(407%)

 

Second Quarter 2014 Key Financial Figures(1) (2)

 


Three Months Ended






June 30,


March 31,





($ in thousands, except per share amounts)

2014


2014


  Change ($)


Change (%)









Total revenues

$         10,862


$           9,143


$           1,719


19%

Research & development  expenses

3,514


7,263


(3,749)


(52%)

Selling, general & administrative expenses

28,139


27,893


246


1%

Non-cash stock-based compensation (3)

1,443


1,393


50


4%

Net loss

(21,575)


(26,533)


4,958


19%









Diluted net loss per share

$            (0.64)


$            (0.79)


$             0.15


19%

 

Select Cash Flow Data(1)(2)  

 


Six Months Ended


June 30,


June 30,

($ in thousands)

2014


2013

Net cash provided by (used in)




Operating activities

$        (60,569)


$        (17,168)

Investing activities

10,756


31,428

Financing activities

2,043


601

 

Select Balance Sheet Data(1)

 


June 30,


December 31


June 30,

($ in thousands)

2014


2013


2013







Total Cash(4)

$         63,585


$       130,350


$       103,633

 

(1) Unaudited.

(2) Prior year amounts have been restated to reflect a change in accounting method for the attribution of stock-based compensation. Refer to footnote 3 in the quarterly report on Form 10Q for the quarter ending June 30, 2014.

(3) Non-cash stock-based compensation is allocated to both Research & development and Selling, general & administrative expenses.

(4) Total Cash reflects cash, cash equivalents and marketable securities

 

OPERATIONAL HIGHLIGHTS  

As of August 6, 2014, over 420 new patient prescriptions have been written for HETLIOZ® in the  U.S. This represents growth of approximately 90% in new prescriptions since the Company's June 4, 2014 commercial update.  HETLIOZ® was launched in the U.S. in April 2014 for the treatment of Non-24, a disorder which affects the majority of totally blind individuals. It is estimated that approximately 80,000 Americans have the disorder.

On July 22, 2014, a new method of use patent was issued by the USPTO for HETLIOZ® in the treatment of Non-24 (patent number 8,785,492).  The '492 patent is expected to expire in 2033, potentially further extending the exclusivity protection of HETLIOZ®. In the U.S., HETLIOZ® is also covered by a composition of matter patent (patent number 5,856,529), which including a Hatch-Waxman 5-year extension is currently expected to expire in 2022.  Both patents, '529 and '492, are now listed in the FDA's Orange Book.   

In June 2014, the EMA accepted for evaluation Vanda's Marketing Authorization Application for oral HETLIOZ® capsules for the treatment of Non-24.    HETLIOZ® was previously granted orphan drug designation by the European Commission for the treatment of Non-24. 

Vanda has initiated development activities for the use of HETLIOZ® in the pediatric population with Non-24, as well as in patients with Smith-Magenis syndrome.

The VLY-686, NK1 antagonist, Phase 2 study in chronic pruritus is ongoing and results are expected in mid-2015.  

2014 FINANCIAL GUIDANCE

Total 2014 operating expenses are expected to be between $110.0 and $120.0 million

To read full press release, please click here.

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