-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, AkQ18iY0ZS+dQnH/VngCyzr6d84M16qxvOnv1rYPdSulWq0QrIakXFZFqxyke6TR HbWmifx986MquMcvL99jNQ== 0001275287-05-002939.txt : 20050802 0001275287-05-002939.hdr.sgml : 20050802 20050802071053 ACCESSION NUMBER: 0001275287-05-002939 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20050802 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20050802 DATE AS OF CHANGE: 20050802 FILER: COMPANY DATA: COMPANY CONFORMED NAME: VICAL INC CENTRAL INDEX KEY: 0000819050 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 930948554 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-21088 FILM NUMBER: 05989938 BUSINESS ADDRESS: STREET 1: 10390 PACIFIC CENTER COURT STREET 2: . CITY: SAN DIEGO STATE: CA ZIP: 92121-4340 BUSINESS PHONE: 858-646-1100 MAIL ADDRESS: STREET 1: 10390 PACIFIC CENTER COURT STREET 2: . CITY: SAN DIEGO STATE: CA ZIP: 92121-4340 8-K 1 vi3262.htm

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 8-K

CURRENT REPORT
Pursuant to Section 13 or 15(d) of
The Securities Exchange Act of 1934

Date of report (Date of earliest event reported):  August 2, 2005

VICAL INCORPORATED
(Exact name of registrant as specified in charter)

Delaware

 

000-21088

 

93-0948554

(State or other jurisdiction
of incorporation)

 

(Commission
File Number)

 

(I.R.S. Employer
Identification No.)

 

 

 

 

 

10390 Pacific Center Court
San Diego, California

 

92121-4340

(Address of principal executive offices)

 

(Zip Code)

 

 

 

 

 

Registrant’s telephone number, including area code: (858) 646-1100

 

 

 

 

 

Not Applicable.

(Former name or former address, if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

o

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

 

o

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

 

o

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

 

o

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 




Item 2.02

Results of Operations and Financial Condition.

          On August 2, 2005, Vical Incorporated issued a press release announcing, among other things, its financial results for the quarter ended June 30, 2005.  A copy of the press release is attached as Exhibit 99.1 to this Current Report.

          The information in this Item 2.02, and Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, regardless of any general incorporation language in such filing.

Item 9.01

Financial Statements and Exhibits.

 

 

          Press release dated August 2, 2005.




SIGNATURES

          Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

VICAL INCORPORATED

 

 

 

Date:  August 2, 2005

By:

/s/ JILL M. CHURCH

 

 


 

 

Jill M. Church

 

 

Vice President, Chief Financial Officer and Secretary




INDEX TO EXHIBITS

Exhibit No.

 

Description


 


 

 

 

99.1

 

Press release issued by Vical Incorporated on August 2, 2005.



EX-99.1 2 vi3262ex991.htm

Exhibit 99.1

Vical Reports Second Quarter 2005 Financial Results

          SAN DIEGO, Aug. 2 /PRNewswire-FirstCall/ -- Vical Incorporated (Nasdaq: VICL) today reported financial results for the quarter ended June 30, 2005.  Revenues for the second quarter of 2005 were $4.8 million compared with $5.7 million for the same period of 2004.  The 2005 revenues consisted primarily of an option exercise fee from Merck & Co., Inc. and an upfront license fee from AnGes MG, Inc., while the prior-year period included revenues from shipments to the National Institutes of Health (NIH) under contract manufacturing agreements.

          The net loss for the second quarter of 2005 was $5.0 million or $0.21 per share, compared with $5.3 million or $0.23 per share for the second quarter of 2004.  Financial results were consistent with the company’s projected net loss for the full year 2005 of between $23 million and $26 million.  Vical had cash and investments of $59 million at the end of the second quarter.

          Recent Highlights

 

*

In July, the grant of the first marketing approval for a product covered by a Vical license agreement, in Canada for APEX-IHN, a DNA vaccine for farm-raised salmon, for Vical’s licensee Aqua Health Ltd., an affiliate of the Swiss-based company Novartis Animal Health.

 

 

 

 

*

Initiation by Vical of a Phase 1 human study in July in which gene-based delivery of interleukin-2 (IL-2) is enhanced with electroporation for patients with recurrent metastatic melanoma.

 

 

 

 

*

Merck’s exercise of three cancer vaccine options in June for which Vical received initial fees of $3.0 million.

 

 

 

 

*

In June, receipt of production orders for HIV vaccines for the NIH totaling $12.1 million, with shipments anticipated in 2005 and 2006 in support of planned Phase 2 studies.

 

 

 

 

*

Orphan drug designation in June for Vical’s immunotherapeutic DNA vaccine against cytomegalovirus (CMV) in certain at-risk transplant patients.  The company expects a Phase 2 study to start by the end of 2005.

 

 

 

 

*

The grant of an exclusive, worldwide license to AnGes in May for DNA-based products encoding Hepatocyte Growth Factor for cardiovascular applications, with an up-front payment to Vical of $1.0 million.  The initial application for peripheral arterial disease is in Phase 3 testing in Japan.

 

 

 

 

*

Encouraging progress in discussions with prospective partners for Allovectin-7(R), and ongoing preparations to allow prompt initiation of a Phase 3 trial if  the company successfully reaches an agreement.




          Conference Call
          Vical will conduct a conference call and webcast to discuss the financial results with invited analysts and institutional investors today, August 2, at noon Eastern Time.  The call and webcast are open on a listen-only basis to any interested parties.  To listen to the conference call, dial (888) 224-3260, or (913) 905-1086 for international participants.  A replay of the call will be available for 48 hours beginning about two hours after the call.  To listen to the replay, dial (888) 203-1112, or (719) 457-0820 for international participants, and enter conference identification number 4825268.  The call also will be available live and archived through the webcast center at www.vical.com.  For further information, contact Vical’s Investor Relations department by phone at (858) 646-1127 or by e-mail at info@vical.com. 

          About Vical
          Vical researches and develops biopharmaceutical products based on its patented DNA delivery technologies for the prevention and treatment of serious or life-threatening diseases.  Potential applications of the company’s DNA delivery technology include DNA vaccines for infectious diseases or cancer, in which the expressed protein is an immunogen; cancer immunotherapeutics, in which the expressed protein is an immune system stimulant; and cardiovascular therapies, in which the expressed protein is an angiogenic growth factor.  The company has retained all rights to its internally developed product candidates.  In addition, the company collaborates with major pharmaceutical companies and biotechnology companies that give it access to complementary technologies or greater resources.  These strategic partnerships provide the company with mutually beneficial opportunities to expand its product pipeline and serve significant unmet medical needs.  Additional information on Vical is available at www.vical.com. 

          This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected, including:  whether the company will achieve the levels of revenues and control expenses to meet projected financial performance; whether the company will reach agreement with one or more potential partners for Allovectin-7(R) or initiate a Phase 3 trial of Allovectin-7(R); whether endpoints in such a trial will be achieved and, if so, whether they will establish sufficient safety and efficacy to support product approval; whether a Phase 2 trial of the bivalent CMV vaccine in transplant patients will begin by the end of 2005, if at all; whether the company will successfully complete Phase 1 testing of its IL-2 treatment for melanoma; whether the NIH will cancel any or all of the $12.1 million of HIV vaccine production orders or whether the company will successfully deliver the full amount, if any, of the vaccines as ordered; and additional risks set forth in the company’s filings with the Securities and Exchange Commission.  These forward-looking statements represent the company’s judgment as of the date of this release.  The company disclaims, however, any intent or obligation to update these forward-looking statements.

Contacts:

Alan R. Engbring

Jill M. Church

 

Executive Director,

Vice President and

 

Investor Relations

Chief Financial Officer

 

(858) 646-1127

 

 

Website:  www.vical.com

 




VICAL INCORPORATED
Selected Condensed Financial Information (Unaudited)

Statements of Operations
(in thousands, except per share amounts)

 

 

Three Months Ended
June 30,

 

Six Months Ended
June 30,

 

 

 


 


 

 

 

2005

 

2004

 

2005

 

2004

 

 

 


 


 


 


 

Revenues:

 

 

 

 

 

 

 

 

 

 

 

 

 

Contract and grant revenue

 

$

487

 

$

3,815

 

$

2,940

 

$

4,102

 

License and royalty revenue

 

 

4,320

 

 

1,927

 

 

4,551

 

 

2,549

 

Total revenues

 

 

4,807

 

 

5,742

 

 

7,491

 

 

6,651

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

4,756

 

 

4,680

 

 

9,229

 

 

10,852

 

Manufacturing and production

 

 

3,353

 

 

3,975

 

 

7,265

 

 

5,978

 

General and administrative

 

 

1,923

 

 

2,535

 

 

4,038

 

 

4,481

 

Total operating expenses

 

 

10,032

 

 

11,190

 

 

20,532

 

 

21,311

 

Loss from operations

 

 

(5,225

)

 

(5,448

)

 

(13,041

)

 

(14,660

)

Net investment income

 

 

243

 

 

132

 

 

481

 

 

269

 

Net loss

 

$

(4,982

)

$

(5,316

)

$

(12,560

)

$

(14,391

)

Basic and diluted net loss per share

 

$

(0.21

)

$

(0.23

)

$

(0.53

)

$

(0.66

)

Shares used to calculate basic and diluted net loss per share

 

 

23,517

 

 

23,476

 

 

23,513

 

 

21,896

 




Balance Sheets
(in thousands)

 

 

June 30,
2005

 

December 31,
2004

 

 

 


 


 

Assets:

 

 

 

 

 

 

 

Cash, cash equivalents, and marketable securities

 

$

59,060

 

$

73,996

 

Other current assets

 

 

4,894

 

 

3,412

 

Total current assets

 

 

63,954

 

 

77,408

 

Property and equipment, net

 

 

15,760

 

 

16,277

 

Other assets

 

 

7,374

 

 

7,541

 

Total assets

 

$

87,088

 

$

101,226

 

Liabilities and stockholders’ equity:

 

 

 

 

 

 

 

Current liabilities

 

$

9,647

 

$

10,108

 

Long-term obligations

 

 

6,823

 

 

8,209

 

Stockholders’ equity

 

 

70,618

 

 

82,909

 

Total liabilities and stockholders’ equity

 

$

87,088

 

$

101,226

 

SOURCE  Vical Incorporated
          -0-                                        08/02/2005
          /CONTACT:  Alan R. Engbring, Executive Director, Investor Relations, or
Jill M. Church, Vice President and Chief Financial Officer, both of Vical
Incorporated, +1-858-646-1127/
          /Web site:  http://www.vical.com /


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