Vanda Pharmaceuticals Reports Third Quarter 2013 Results

Nov 07, 2013, 06:55 ET from Vanda Pharmaceuticals Inc.

WASHINGTON, Nov. 7, 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 third quarter ended September 30, 2013.

Key Highlights:

  • On July 29, 2013 Vanda announced that the U.S. Food and Drug Administration (FDA) accepted the filing of and granted priority review classification to Vanda's New Drug Application (NDA) for tasimelteon, a circadian regulator for the treatment of Non-24-Hour Disorder (Non-24) in the totally blind.
  • The FDA has scheduled a Peripheral and Central Nervous System Drugs Advisory Committee Meeting on November 14, 2013, for the review of Vanda's NDA for tasimelteon, proposed trade name HETLIOZ, for the treatment of Non-24.
  • The FDA determined the action target date under the Prescription Drug User Fee Act (PDUFA-V) for tasimelteon to be January 31, 2014. 
  • On August 7, 2013 Vanda completed the public offering of 4.68 million shares of common stock resulting in net proceeds of $48.6 million
  • Vanda recorded third quarter 2013 revenue of $8.7 million including royalties of $2.0 million.  Fanapt® prescriptions, as reported by IMS, were approximately 43,600 for the third quarter of 2013.  This represents a 13% increase over third quarter 2012 prescriptions and a 5% increase over second quarter 2013 prescriptions.

THIRD QUARTER 2013 REPORTED RESULTS

Total revenues for the third quarter of 2013 were $8.7 million, compared to $8.3 million for the same period in 2012.  Third quarter 2013 revenues included $2.0 million in Fanapt® royalties received from Novartis as compared to royalties of $1.5 million for the third quarter of 2012.

Total operating expenses for the third quarter of 2013 were $14.1 million, compared to $13.7 million for the third quarter of 2012.  Third quarter 2013 research and development expenses of $8.0 million includes $3.5 million in milestones associated with the FDA acceptance of the tasimelteon filing.  The primary driver of the lower research and development expenses in the third quarter of 2013 as compared to $10.2 million in the third quarter of 2012 was the completion of the tasimelteon Non-24 and Major Depressive Disorder efficacy studies.  General and administrative expenses of $5.7 million for the third quarter of 2013 were $2.6 million higher than the third quarter of 2012 and reflect the increased commercial activity in preparation for a potential tasimelteon commercial launch in the United States.

Vanda recorded a net loss of $5.4 million for the third quarter of 2013, compared to a net loss of $5.3 million for the same period in 2012.  Diluted net loss per share for the third quarter of 2013 was $0.17, compared to a diluted net loss per share of $0.19 for the third quarter of 2012.

Cash, cash equivalents and marketable securities (Cash) increased by $38.5 million to $142.2 million as of September 30, 2013, primarily as a result of the sale of common stock in Vanda's public offering in August 2013.  

Year to Date September 30, 2013 Key Financial Figures1

Nine Months Ended

September 30

September 30

($ in thousands, except per share amounts)

2013

2012

  Change ($)

Change (%)

Total revenues

$         25,096

$         24,807

$             289

1%

Research & development  expenses

21,968

34,829

(12,861)

(37%)

General & administrative expenses

14,743

10,657

4,086

38%

Non-cash stock-based compensation2

3,321

3,171

150

5%

Net loss

(12,632)

(21,295)

8,663

41%

Diluted net loss per share

$            (0.43)

$            (0.75)

$            0.32

43%

 Third Quarter 2013 Key Financial Figures1

Three Months Ended

September 30

June 30

($ in thousands, except per share amounts)

2013

2013

  Change ($)

Change (%)

Total revenues

$           8,709

$           8,319

$             390

5%

Research & development  expenses

8,026

5,982

2,044

34%

General & administrative expenses

5,711

5,074

637

13%

Non-cash stock-based compensation2

1,539

830

709

85%

Net loss

(5,380)

(3,079)

(2,301)

(75%)

Diluted net loss per share

$            (0.17)

$            (0.11)

$          (0.06)

(55%)

Select Cash Flow Data1

Nine Months Ended

September 30

September 30

($ in thousands)

2013

2012

Net cash provided by (used in)

Operating activities

$ (27,439)

$ (31,068)

Investing activities

31,421

47,660

Financing activities

49,418

-

 Select Balance Sheet Data1

September 30

June 30

September 30

($ in thousands)

2013

2013

2012

Total cash and marketable securities

$       142,172

$       103,633

$      134,404

(1) Unaudited

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

 

OPERATIONAL HIGHLIGHTS

On July 29, 2013, Vanda announced that the FDA accepted the filing of and granted a priority review classification to Vanda's NDA for tasimelteon, a circadian regulator for the treatment of Non-24 in the totally blind.  Currently, there is no approved treatment for Non-24 and tasimelteon has the potential to address this unmet medical need.  The FDA has scheduled a Peripheral and Central Nervous System Drugs Advisory Committee Meeting on November 14, 2013, for the review of Vanda's NDA for tasimelteon, proposed trade name HETLIOZ, for the treatment of Non-24.  The FDA determined the action target date under the Prescription Drug User Fee Act (PDUFA-V) for tasimelteon to be January 31, 2014. 

Vanda recorded third quarter 2013 revenue of $8.7 million including $6.7 million in licensing revenue related to the amortization of the upfront payment received from Novartis for U.S. and Canadian commercial rights to Fanapt® and Fanapt® royalties of $2.0 million.  Fanapt® prescriptions, as reported by IMS, were approximately 43,600 for the third quarter of 2013.  This represents a 13% increase over third quarter 2012 prescriptions and a 5% increase versus second quarter 2013 prescriptions.  

2013 FINANCIAL GUIDANCE

2013 expenses are expected to reflect lower research and development spending as compared to 2012 and an increase in commercial spending.  Reflecting the recent public offering and year to date expenditures, Vanda now expects that it will end the year with between $130.0 and $135.0 million in Cash.  Total 2013 operating expenses are expected to be between $50.0 and $55.0 million and decrease in Cash, excluding the impact of the recent public offering, is expected to be between $35.0 and $40.0 million.

CONFERENCE CALL

Vanda has scheduled a conference call for today, Thursday, November 7, 2013, at 10:00 AM ET.  During the call, Vanda's management will discuss the third quarter 2013 financial results and other corporate activities.  Investors can call 1-888-895-5271 (domestic) and 1-847-619-6547 (international) and use passcode 35919679.  A replay of the call will be available beginning Thursday, November 7, 2013 at 12:00 PM ET and will be accessible until Thursday, November 14, 2013, at 5:00 PM ET.  The replay call-in number is 1-888-843-7419 for domestic callers and 1-630-652-3042 for international callers.  The access number is 35919679.

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.

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 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: Vanda's failure to obtain, or any delay in obtaining, regulatory approval for tasimelteon for the treatment of Non-24-Hour Disorder or to comply with ongoing regulatory requirements; the costs and effects of current or potential litigation 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, 2012 which is on file with the SEC and available on the SEC's website at www.sec.gov and Vanda's quarterly report on Form 10-Q for the quarter ended September 30, 2013 to be filed with the SEC.  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.

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

Nine Months Ended

September 30

September 30

September 30

September 30

($ in thousands, except per share amounts)

2013

2012

2013

2012

Revenues:

Licensing agreement

$

6,753

$

6,753

$

20,037

$

20,037

Royalty revenue

1,956

1,535

5,059

4,770

Total revenues

8,709

8,288

25,096

24,807

Operating expenses:

Research and development

8,026

10,159

21,968

34,829

General and administrative

5,711

3,147

14,743

10,657

Intangible asset amortization

377

377

1,118

1,118

Total operating expenses

14,114

13,683

37,829

46,604

Loss from operations

(5,405)

(5,395)

(12,733)

(21,797)

Other income

25

69

101

502

Loss before tax benefit

(5,380)

(5,326)

(12,632)

(21,295)

Tax benefit

-

-

-

-

Net loss

$

(5,380)

$

(5,326)

$

(12,632)

$

(21,295)

Net loss per share:

Basic

$

(0.17)

$

(0.19)

$

(0.43)

$

(0.75)

Diluted

$

(0.17)

$

(0.19)

$

(0.43)

$

(0.75)

Shares used in calculations of net loss

per share:

Basic

31,332,993

28,226,743

29,363,162

28,226,743

Diluted

31,332,993

28,226,743

29,363,162

28,226,743

 

VANDA PHARMACEUTICALS INC.

 CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited)

($ in thousands)

September 30, 2013

December 31, 2012

ASSETS

Current assets:

Cash and cash equivalents

$

142,172

$

88,772

Marketable securities

-

31,631

Accounts receivable

1,956

1,168

Prepaid expenses and other current assets

2,412

3,967

Restricted cash, current

530

430

Total current assets

147,070

125,968

Property and equipment, net

2,106

2,348

Intangible asset, net

5,414

6,532

Restricted cash, non-current

500

600

Total assets

$

155,090

$

135,448

LIABILITIES AND STOCKHOLDERS' EQUITY

Current liabilities:

Accounts payable

$

369

$

287

Accrued liabilities

4,532

5,187

Deferred rent, current

215

-

Deferred revenues, current

26,789

26,789

Total current liabilities

31,905

32,263

Deferred rent, non-current

2,945

3,005

Deferred revenues, non-current

70,238

90,275

Total liabilities

105,088

125,543

Stockholders' equity:

Common stock

33

28

Additional paid-in capital

353,708

300,974

Accumulated other comprehensive income

-

10

Accumulated deficit

(303,739)

(291,107)

Total stockholders' equity

50,002

9,905

Total liabilities and stockholders' equity

$

155,090

$

135,448

INVESTOR CONTACT: Chad Rubin Vice President The Trout Group (646) 378-2947 crubin@troutgroup.com

SOURCE Vanda Pharmaceuticals Inc.



RELATED LINKS

http://www.vandapharma.com