Vanda Pharmaceuticals Reports Fourth Quarter 2012 and Full Year 2012 Results

Feb 12, 2013, 06:55 ET from Vanda Pharmaceuticals Inc.

WASHINGTON, Feb. 12, 2013 /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 fourth quarter and full year ended December 31, 2012.

Key Highlights:

  • Vanda reported positive SET and RESET Phase III efficacy studies for tasimelteon in the treatment of patients with Non-24-Hour Disorder (Non-24).  Study results demonstrate tasimelteon is a unique circadian regulator that resets the master body clock and improves clinical symptoms in patients with Non-24.
  • The tasimelteon Non-24 program continues towards the goal of a projected mid-2013 New Drug Application (NDA) filing with the U.S. Food and Drug Administration (FDA). 
  • All tasimelteon activities have been discontinued related to the Major Depressive Disorder (MDD) indication.  In January 2013, Vanda announced that the MAGELLAN Phase IIb/III clinical study did not meet its primary endpoint.
  • Vanda has formally requested a re-examination of the negative opinion issued by the European Medicines Agency (EMA) recommending against approval of Fanaptum (oral iloperidone tablets) in the European Union. 
  • Vanda recorded full year 2012 revenue of $32.7 million including Fanapt® royalties of $5.9 million.  Fanapt® prescriptions, as reported by IMS, were approximately 38,200 for the fourth quarter of 2012.  This represents a 1% decrease versus third quarter 2012 prescriptions and a 13% increase over fourth quarter 2011 prescriptions.   

FULL YEAR 2012 REPORTED RESULTS

Total revenues for the full year 2012 were $32.7 million, compared to $31.3 million for 2011.  Full year 2012 revenues included $5.9 million in Fanapt® royalties received from Novartis, as compared to $4.5 million for the prior year.  Both 2012 and 2011 revenues include $26.8 million recognized from the $200.0 million upfront payment previously received from Novartis for Fanapt® U.S. and Canadian rights. 

Total operating expenses for 2012 were $61.0 million, compared to $42.0 million for 2011.  The primary driver of the higher expenses in 2012 was the ongoing support of the tasimelteon Non-24 and MDD clinical studies.

Vanda recorded a net loss of $27.7 million for 2012, compared to net loss of $9.8 million for 2011.  Diluted net loss per share for 2012 was $0.98, compared to a diluted net loss per share of $0.35 for 2011.

Vanda's cash, cash equivalents and marketable securities as of December 31, 2012 totaled $120.4 million.

FOURTH QUARTER 2012 REPORTED RESULTS

Total revenues for the fourth quarter of 2012 were $7.9 million, compared to $8.4 million for 2011. Fourth quarter 2012 revenues included $1.2 million in Fanapt® royalties received from Novartis as compared to royalties of $1.6 million for the fourth quarter of 2011.   

Total operating expenses for the fourth quarter of 2012 and 2011 were each $14.3 million.

Vanda recorded a net loss of $6.4 million for the fourth quarter of 2012, compared to a net loss of $5.5 million for the fourth quarter of 2011.  Diluted net loss per share for the fourth quarter of 2012 was $0.23, compared to a diluted net loss of $0.20 per share for the fourth quarter of 2011.

 

Full Year December 31, 2012 Key Financial Figures1

 

Twelve Months Ended

December 31

December 31

(in thousands, except per share amounts)

2012

2011

  Change ($)

Change (%)

Total revenues

$         32,727

$         31,270

$           1,457

5%

Research & development  expenses

45,446

28,996

16,450

57%

General & administrative expenses

13,882

11,486

2,396

21%

Non-cash stock-based compensation2

4,094

5,501

(1,407)

(26%)

Loss before tax benefit

(27,664)

(10,246)

(17,418)

(170%)

Tax benefit

-

(444)

444

100%

Net loss

(27,664)

(9,802)

(17,862)

(182%)

Diluted net loss per share

$            (0.98)

$            (0.35)

$            (0.63)

(180%)

 

Fourth Quarter 2012 Key Financial Figures1

Three Months Ended

December 31

September 30

(in thousands, except per share amounts)

2012

2012

  Change ($)

Change (%)

Total revenues

$           7,920

$           8,288

$             (368)

(4%)

Research & development  expenses

10,617

10,159

458

5%

General & administrative expenses

3,225

3,147

78

2%

Non-cash stock-based compensation2

923

576

347

60%

Loss before tax benefit

(6,369)

(5,326)

(1,043)

(20%)

Tax benefit

-

-

-

Net loss

(6,369)

(5,326)

(1,043)

(20%)

Diluted net loss per share

$            (0.23)

$            (0.19)

$            (0.04)

(21%)

 

Select Cash Flow Data1

Twelve Months Ended

December 31

December 31

(in thousands)

2012

2011

Net cash provided by (used in)

Operating activities

$        (44,917)

$        (28,410)

Investing activities

45,754

73,749

Financing activities

12

25

 

Select Balance Sheet Data1

December 31

September 30

December 31

(in thousands)

2012

2012

2011

Total cash and marketable securities

$       120,403

$       134,404

$       167,896

(1) Unaudited

(2) Non-cash stock-based compensation is allocated to both Research & development and General & administrative expenses

OPERATIONAL HIGHLIGHTS

In December 2012 and January 2013, Vanda announced positive results for two Phase III studies for tasimelteon in the treatment of Non-24.  The SET Phase III study demonstrated that tasimelteon was able to entrain the master body clock as measured by melatonin and cortisol circadian rhythms.  Tasimelteon was also shown to significantly improve clinical symptoms across a number of sleep and wake measures.  These results provided robust evidence of direct and clinically meaningful benefits to patients with Non-24.  The RESET Phase III study demonstrated the maintenance effect of 20mg of tasimelteon to entrain melatonin and cortisol circadian rhythms in individuals with Non-24.   Patients treated with tasimelteon maintained their clinical benefits while patients receiving placebo showed significant deterioration in measures of nighttime sleep, daytime naps and timing of sleep.  Non-24 is a serious, rare circadian rhythm disorder that affects a majority of totally blind individuals who lack light perception and cannot entrain (reset) their master body clock to the 24-hour day.  Currently there is no approved treatment for Non-24.

Vanda plans to submit an NDA to the FDA in mid-2013.  Vanda will meet with the FDA in Q1 of 2013 for a pre-NDA meeting on tasimelteon in the treatment of patients with Non-24.

Vanda has decided to discontinue all activities related to the MDD indication.  In January, Vanda announced that the MAGELLAN Phase IIb/III clinical study in MDD did not meet the primary endpoint of a change from baseline in the Hamilton Depression Scale (HAMD-17) after 8 weeks of treatment as compared to placebo. 

Vanda has formally appealed the EMA's negative opinion for Fanaptum (oral iloperidone tablets) and requested a re-examination of the decision by the EMA's Committee for Medicinal Product for Human Use (CHMP).  In December 2012, the CHMP issued a negative opinion recommending against approval of Fanaptum for the treatment of schizophrenia in adult patients in the European Union.  

Vanda recorded full year 2012 revenue of $32.7 million including Fanapt® royalties of $5.9 million.  Fanapt® prescriptions, as reported by IMS, were approximately 38,200 for the fourth quarter of 2012.  This represents a 1% decrease versus third quarter 2012 prescriptions and a 13% increase over fourth quarter 2011 prescriptions.  

CONFERENCE CALL

Vanda has scheduled a conference call for today, Tuesday, February 12, 2013, at 10:00 AM ET.  During the call, Vanda's management will discuss the fourth quarter and full year 2012 results and other corporate activities.  Investors can call 800-901-5248 (domestic) and 617-786-4512 (international) and use passcode 86594010.  A replay of the call will be available beginning Tuesday, February 12, 2013 at 12:00 PM ET and will be accessible until Tuesday, February 19, 2013, at 5:00 PM ET.  The replay call-in number is 1-888-286-8010 for domestic callers and 1-617-801-6888 for international callers.  The access number is 89804635.

The conference call will be broadcast simultaneously on Vanda's website, http://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, through March 14, 2013.

ABOUT VANDA PHARMACEUTICALS INC.:

Vanda Pharmaceuticals Inc. is a biopharmaceutical company focused on the development and commercialization of products for the treatment of central nervous system disorders.  For more on Vanda, please visit http://www.vandapharma.com.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

Various statements in this release are "forward-looking statements" under the securities laws. Words such as, but not limited to, "believe," "expect," "anticipate," "estimate," "intend," "plan," "project," "target," "goal," "likely," "will," "would," and "could," or the negative of these terms and similar expressions or words, identify forward-looking statements. 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 the company's forward-looking statements include, among others: the inability to reach agreement with the FDA regarding Vanda's regulatory approval strategy or proposed path to approval for tasimelteon for the treatment of Non-24; Vanda's failure to obtain regulatory approval for tasimelteon for the treatment of Non-24 or to comply with ongoing regulatory requirements; the extent and effectiveness of the development, sales and marketing and distribution support Fanapt® receives; Vanda's ability to successfully commercialize Fanapt® outside of the U.S. and Canada 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, 2011 which is on file with the SEC and available on the SEC's website at www.sec.gov.  In addition to the risks described above and in Vanda's annual report on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and other filings with the SEC, 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 (Unaudited)

Three Months Ended

Twelve Months Ended

(in thousands, except for share)

December 31

December 31

December 31

December 31

and per share amounts)

2012

2011

2012

2011

Revenues:

Licensing agreement

$

6,752

$

6,752

$

26,789

$

26,789

Royalty revenue

1,168

1,618

5,938

4,481

Total revenues

7,920

8,370

32,727

31,270

Operating expenses:

Cost of sales

129

-

129

-

Research and development

10,617

10,556

45,446

28,996

General and administrative

3,225

3,345

13,882

11,486

Intangible asset amortization

377

377

1,495

1,495

Total operating expenses

14,348

14,278

60,952

41,977

Loss from operations

(6,428)

(5,908)

(28,225)

(10,707)

Other income

59

99

561

461

Loss before tax benefit

(6,369)

(5,809)

(27,664)

(10,246)

Tax benefit

-

(286)

-

(444)

Net loss

$

(6,369)

$

(5,523)

$

(27,664)

$

(9,802)

Net loss per share:

Basic

$

(0.23)

$

(0.20)

$

(0.98)

$

(0.35)

Diluted

$

(0.23)

$

(0.20)

$

(0.98)

$

(0.35)

Shares used in calculation of net loss

per share:

Basic 

28,233,409

28,115,175

28,228,409

28,106,831

Diluted

28,233,409

28,115,175

28,228,409

28,106,831

VANDA PHARMACEUTICALS INC.

 CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited)

(in thousands)

December 31, 2012

December 31, 2011

ASSETS

Current assets:

Cash and cash equivalents

$

88,772

$

87,923

Marketable securities, current

31,631

60,961

Accounts receivable

1,168

1,618

Inventory

57

-

Prepaid expenses and other current assets

3,910

2,999

Restricted cash, current

430

-

Total current assets

125,968

153,501

Marketable securities, non-current

-

19,012

Property and equipment, net

2,348

964

Other assets, non-current

-

84

Intangible asset, net

6,532

8,027

Restricted cash, non-current

600

1,030

Total assets

$

135,448

$

182,618

LIABILITIES AND STOCKHOLDERS' EQUITY

Current liabilities:

Accounts payable

$

287

$

996

Accrued liabilities

5,187

3,381

Deferred rent, current

-

453

Deferred revenues, current

26,789

26,789

Total current liabilities

32,263

31,619

Non-current liabilities:

Deferred rent, non-current

3,005

461

Deferred revenues, non-current

90,275

117,064

Total liabilities

125,543

149,144

Stockholders' equity:

Common stock

28

28

Additional paid-in capital

300,974

296,868

Accumulated other comprehensive income

10

21

Accumulated deficit

(291,107)

(263,443)

Total stockholders' equity

9,905

33,474

Total liabilities and stockholders' equity

$

135,448

$

182,618

COMPANY CONTACT: Cristina Murphy Senior Communications Manager Vanda Pharmaceuticals Inc. (202) 734-3414 cristina.murphy@vandapharma.com

SOURCE Vanda Pharmaceuticals Inc.



RELATED LINKS

http://www.vandapharma.com