-----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, CsbNgB/DDBusIYn5rL5k0NuQET1R+mxV53Z3oNJGxBns/Tz86GQPnBVLuQLA1iWH GrTLj4qU9IM61ShMyVi5Jg== 0001104659-07-038101.txt : 20070510 0001104659-07-038101.hdr.sgml : 20070510 20070510132713 ACCESSION NUMBER: 0001104659-07-038101 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20070510 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20070510 DATE AS OF CHANGE: 20070510 FILER: COMPANY DATA: COMPANY CONFORMED NAME: FAVRILLE INC CENTRAL INDEX KEY: 0001285701 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 330892797 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-51134 FILM NUMBER: 07836395 MAIL ADDRESS: STREET 1: 10421 PACIFIC CENTER COURT STREET 2: STE 150 CITY: SAN DIEGO STATE: CA ZIP: 92121 8-K 1 a07-13688_18k.htm 8-K

 

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): May 10, 2007

FAVRILLE, INC.

(Exact Name of Registrant as Specified in Charter)

DELAWARE

 

000-51134

 

33-0892797

(State or Other Jurisdiction of Incorporation)

 

(Commission File Number)

 

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

 

10445 PACIFIC CENTER COURT

 

 

SAN DIEGO, CALIFORNIA

 

92121

(Address of Principal Executive Offices)

 

(Zip Code)

 

(858) 526-8000

(Registrants telephone number, including area code)

N/A

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

Check the appropriate box below if the Form 8-K 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 CRF 240.13e-4(c))

 




Item 2.02               Results of Operations and Financial Condition.

On May 10, 2007, the registrant issued a press release announcing its financial results for the quarter ended March 31, 2007.  A copy of the press release and accompanying information is attached as Exhibit 99.1 to this Current Report.

                During the earnings call held on May 10, 2007, the Company presented the non-GAAP financial measure “cash burn,” which the Company defines as the net cash used in operating activities, as determined in accordance with GAAP, adjusted for the effects of purchases of property and equipment, payments on debt obligations, proceeds from debt and realized premium/discount on short-term investments, all being determined in accordance with GAAP.  Cash burn should be considered in addition to, not as a substitute for, or superior to, financial measures calculated in accordance with GAAP.  The Company’s management believes that cash burn is an important measure for investors, as it indicates the rate at which the Company is using its total cash and investment balances for general business activities.  The Company’s management also believes that the presentation of this non-GAAP financial measure will enable investors, analysts and readers of the financial statements to compare non-GAAP measures with relevant GAAP measures in all periods presented. The calculations of cash burn for the three months ended March 31, 2007 are as follows (in millions):

 

 

Three Months Ended

 

Actual

 

March 31, 2007

 

 

 

(unaudited)

 

Net cash used in operating activities

 

$

10.1

 

Purchase of property and equipment

 

4.0

 

Proceeds from debt

 

(4.4

)

Payments on debt

 

1.2

 

Realized premium/discount on short-term investments

 

(0.2

)

 

 

 

 

Cash burn

 

$

10.7

 

 

The information in this Item 2.02, and in 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.  The information in this Current Report shall not be incorporated by reference into any registration statement or other document filed with the Securities and Exchange Commission, whether filed before or after the date hereof, regardless of any general incorporation language in any such filing, unless the registrant expressly sets forth in such filing that such information is to be considered “filed” or incorporated by reference therein.

2




Item 9.01.  Financial Statements and Exhibits.

(d)       Exhibits

99.1        Press release of the registrant dated May 10, 2007.

3




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.

 

FAVRILLE, INC.

 

 

 

 

 

By:

/s/ Tamara A. Seymour

Date: May 10, 2007

 

 

Tamara A. Seymour

 

 

 

Chief Financial Officer

 

4




INDEX TO EXHIBITS

99.1     Press release of the registrant dated May 10, 2007.

 

5



EX-99.1 2 a07-13688_1ex99d1.htm EX-99.1

EXHIBIT 99.1

Company Contacts:

 

 

Tamara A. Seymour

 

Pete De Spain

CFO and Vice President,

 

Director, Investor Relations

Finance & Administration

 

& Corporate Communications

Favrille, Inc.

 

Favrille, Inc.

(858) 526-8035

 

(858) 526-2426

tseymour@favrille.com

 

pdespain@favrille.com

 

Favrille Reports First Quarter 2007 Financial Results

San Diego — May 10, 2007 — Favrille, Inc. (Nasdaq: FVRL), a biopharmaceutical company developing patient-specific, active immunotherapies for the treatment of cancer, today reported its financial results for the first quarter ended March 31, 2007. Net loss for the quarter was $10.5 million, or $0.34 per share, compared to $10.9 million, or $0.49 per share for the same period in 2006.

“We are approaching the end of the pivotal Phase 3 clinical trial for our lead product candidate, FavId®, for the treatment of B-cell non-Hodgkin’s lymphoma (NHL),” said John P. Longenecker, Ph.D., President and Chief Executive Officer of Favrille. “We completed enrollment in this trial in January 2006 and now eagerly await the analysis of our primary endpoint, time to disease progression (TTP). The trigger for this analysis is based upon the number of patients whose disease progresses and is currently projected to occur around the end of this year. We will closely monitor the rate of progression in the coming months and update this projection as necessary. We are currently in the process of validating our commercial-scale manufacturing facility and have begun preparations for the filing of our Biologics License Application.”

First Quarter 2007 Financial Review

Research and development expense was approximately $8.0 million for the first quarter of 2007, compared to approximately $8.4 million for the same period in 2006. The decrease is primarily due to a decrease in Phase 3 clinical trial expense related to the completion of patient enrollment into the Company’s pivotal Phase 3 clinical trial in January 2006, offset by an increase in utilities, maintenance, depreciation and lease expenses and laboratory supplies associated with the commercial-scale facility expansion.

Marketing, general and administrative expense was approximately $2.9 million for the first quarter of 2007, compared to approximately $2.7 million during the same period in 2006. The increase primarily reflects an increase in compensation costs associated with additional administrative personnel and stock-based compensation, offset by a decrease in outside services related to strategic marketing programs and consulting services related to a software implementation project expensed in 2006.

As of March 31, 2007, cash, cash equivalents and short term investments were approximately $41.9 million, compared to $42.4 million at December 31, 2006. The decrease resulted primarily




from net cash used to fund ongoing operations partially offset by the $10 million in gross proceeds from the registered direct offering of common stock in February 2007.

“We expect total operating expenses for the full year 2007 to be in the range of $48 million to $52 million, including an estimated $4 million to $5 million in stock-based compensation,” said Tamara A. Seymour, Chief Financial Officer of Favrille. “We believe our cash on hand along with access to the committed equity financing facility we established with Kingsbridge Capital Limited in December 2006 should be sufficient to fund operations for at least 12 months.”

Recent Highlights

·                  Appointed Chief Medical Officer. Earlier this week Favrille appointed Richard Ghalie, M.D., as Chief Medical Officer to direct the Company’s medical research activities. A licensed hematologist and oncologist, Dr. Ghalie comes to Favrille with nearly 15 years of experience in the biopharmaceutical industry and a strong background in clinical development, FDA interactions, product approvals and launch, as well as post-marketing studies and support. He served most recently as Vice President of Medical Affairs and Professional Services at Ligand Pharmaceuticals Inc.

·                  Reported Positive Data at AACR. Favrille announced results from a new study showing enhanced activity from insect-cell derived idiotype proteins, a key component in the Company’s Id/KLH immunotherapy product candidate FavId for B-cell NHL, compared to idiotype proteins produced using mammalian cells. The data were reported at the American Association for Cancer Research (AACR) Annual Meeting last month in Los Angeles.

·                  Entered Agreements with Expression Systems. Favrille recently entered into five-year supply and license agreements with Expression Systems LLC for insect cell growth media that Favrille uses in the production of FavId. Under the terms of the agreements, Favrille has the right to purchase raw material components from Expression Systems and manufacture the cell growth media in-house. Each agreement is also renewable for one three-year period at Favrille’s option, ensuring a long-term supply in preparation for commercialization of FavId.

·                  Entered Agreement with Berlex. Favrille also entered into an agreement with Berlex, Inc., a U.S. affiliate of Bayer Schering Pharma AG, Germany, in February. This agreement helps pave the way for commercialization, including reimbursement, of FavId in combination with Berlex’s Leukine® (sargramostim, GM-CSF), a growth factor designed to enhance a patient’s immune response.

·                  Raised $10 Million in Registered Direct Offering. Favrille completed a $10 million registered direct common stock offering in February. Selected investors, including leading life sciences institutional investor Federated Kaufmann Fund, purchased 3.3 million shares of the Company’s common stock at a price of $3.00 per share pursuant to an effective shelf registration statement.

Conference Call and Webcast Information

Favrille management will host a conference call today to discuss the first quarter 2007 financial results at 4:30 p.m. Eastern Time. A live audio webcast of management’s presentation will be

2




available at www.favrille.com. Alternatively, callers may participate in the conference call by dialing (800) 659-2037 or (617) 614-2713, passcode 83529659. A telephone replay of the call will also be available for 48 hours. The telephone replay can be accessed by dialing (888) 286-8010 or (617) 801-6888, passcode 58275228.

About Favrille, Inc.

Favrille, Inc. is a biopharmaceutical company focused on the research, development and commercialization of targeted immunotherapies for the treatment of cancer and other diseases of the immune system. The Company’s lead product candidate, FavId, is based upon unique genetic information extracted from a patient’s tumor. FavId is currently under investigation in a pivotal Phase 3 clinical trial for patients with follicular B-cell NHL and Phase 2 clinical trials in other B-cell NHL indications. The Company is developing additional applications based on its immunotherapy expertise and proprietary cost-effective manufacturing technology, including a second product candidate, FAV-201, for the treatment of T-cell lymphoma.

# # #

Statements in this press release that are not strictly historical in nature constitute “forward-looking statements.” Such statements include, but are not limited to, references to Favrille’s product candidates, proprietary technologies and research programs. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Favrille’s actual results to be materially different from historical results or from any results expressed or implied by such forward-looking statements. These factors include, but are not limited to, risks and uncertainties related to progress and timing of clinical trials for FavId, including difficulties or delays in development, testing, manufacturing and marketing FavId or Favrille’s other product candidates; delays in the availability of data from Favrille’s Phase 3 clinical trial; Favrille’s ability to obtain marketing approval for FavId or Favrille’s other product candidates and the timing of any such approvals, including whether a clinically meaningful response improvement can serve as the basis for accelerated approval of FavId and whether it will receive expedited review as a result of the Fast Track designation; Favrille’s ability to demonstrate that its idiotype protein produced from insect cell lines may stimulate a more effective immune response compared to idiotype protein derived from mammalian cells; Favrille’s ability to manufacture sufficient quantities of FavId for use in clinical trials and, if FavId receives marketing approval, for commercialization; risks associated with achieving projected operating metrics and financial performance or the anticipated number of patients using FavId; potential delays in patient enrollment; Favrille’s ability to obtain additional financing to support its operations; and additional risks discussed in Favrille’s filings with the Securities and Exchange Commission. In addition, conclusions regarding the safety and efficacy of Favrille’s product candidates cannot be made until the results of future clinical trials of longer duration in more patients are known. All forward-looking statements are qualified in their entirety by this cautionary statement. Favrille is providing this information as of the date of this release and, except as required by law, does not undertake any obligation to update any forward-looking statements contained in this release as a result of new information, future events or otherwise.

3




FAVRILLE, INC.

(a development stage company)

BALANCE SHEETS

(in thousands, except share and per share data)

 

 

March 31,
2007

 

December 31,
2006

 

 

 

(unaudited)

 

 

 

Assets

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

22,188

 

$

14,249

 

Short-term investments

 

19,699

 

28,160

 

Receivables

 

265

 

242

 

Prepaid expenses and other current assets

 

1,010

 

608

 

Total current assets

 

43,162

 

43,259

 

Property and equipment, net

 

32,314

 

25,071

 

Restricted cash

 

3,451

 

3,451

 

Other assets

 

497

 

508

 

Total assets

 

$

79,424

 

$

72,289

 

Liabilities and stockholders’ equity

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable and accrued liabilities

 

$

5,838

 

$

6,779

 

Current portion of debt

 

5,848

 

4,976

 

Total current liabilities

 

11,686

 

11,755

 

Debt, less current portion

 

8,095

 

5,754

 

Deferred rent

 

14,280

 

10,145

 

Commitments and contingencies

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

Preferred stock, $0.001 par value 5,000,000 shares authorized at March 31, 2007 and December 31, 2006; no shares issued and outstanding at March 31, 2007 and December 31, 2006

 

 

 

Common stock, $0.001 par value: Authorized shares, 75,000,000 at March 31, 2007 and December 31, 2006; Issued and outstanding shares— 32,503,721 and 29,060,081 at March 31, 2007 and December 31, 2006, respectively

 

33

 

29

 

 

 

Additional paid-in capital

 

211,754

 

200,497

 

Accumulated other comprehensive loss

 

1

 

3

 

Deficit accumulated during the development stage

 

(166,425

)

(155,894

)

Total stockholders’ equity

 

45,363

 

44,635

 

Total liabilities and stockholders’ equity

 

$

79,424

 

$

72,289

 

 

4




FAVRILLE, INC.

(a development stage company)

STATEMENTS OF OPERATIONS

(in thousands, except per share data)

 

 

Three Months ended March 31,

 

 

 

2007

 

2006

 

Operating expenses:

 

 

 

 

 

Research and development

 

$

7,997

 

$

8,421

 

General and administrative

 

2,912

 

2,701

 

Total operating expenses

 

10,909

 

11,122

 

Interest income

 

565

 

432

 

Interest expense and other

 

(187

)

(165

)

Other income (expense)

 

 

 

Total other income, net

 

378

 

267

 

Net loss and net loss applicable to common stockholders

 

$

(10,531

)

$

(10,855

)

Historical net loss per share:

 

 

 

 

 

Basic and diluted

 

$

(0.34

)

$

(0.49

)

Weighted-average shares-basic and diluted

 

30,690

 

22,355

 

 

5




FAVRILLE, INC.

(a development stage company)

STATEMENTS OF CASH FLOWS

(in thousands)

Unaudited

 

 

Three Months ended

 

 

 

March 31,

 

 

 

2007

 

2006

 

Operating activities

 

 

 

 

 

Net loss

 

$

(10,531

)

$

(10,855

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

Depreciation and amortization

 

659

 

511

 

Stock-based compensation

 

1,054

 

879

 

Amortization of premium/discount on short-term investments

 

(177

)

1

 

Other

 

36

 

131

 

Changes in operating assets and liabilities:

 

 

 

 

 

Other assets

 

(420

)

(448

)

Accounts payable and accrued liabilities

 

(1,178

)

1,462

 

Deferred rent

 

466

 

418

 

Net cash used in operating activities

 

(10,091

)

(7,901

)

Investing activities

 

 

 

 

 

Purchases of property and equipment

 

(3,990

)

(932

)

Purchases of short-term investments

 

(6,263

)

(5,909

)

Maturities of short-term investments

 

14,900

 

8,650

 

Net cash from investing activities

 

4,647

 

1,809

 

Financing activities

 

 

 

 

 

Proceeds from debt

 

4,362

 

315

 

Payments on debt

 

(1,186

)

(557

)

Issuance of common stock and warrants

 

10,207

 

45,168

 

Repurchase of restricted common stock

 

 

(1

)

Net cash provided by financing activities

 

13,383

 

44,925

 

Net increase in cash and cash equivalents

 

7,939

 

38,833

 

Cash and cash equivalents at beginning of period

 

14,249

 

12,065

 

Cash and cash equivalents at end of period

 

$

22,188

 

$

50,898

 

 

 

 

 

 

 

Supplemental schedule of non-cash investing and financing activities:

 

 

 

 

 

Capitalized interest recorded as property, plant and equipment

 

127

 

 

 

Accrued asset acquisitions

 

238

 

 

 

Leasehold improvements acquired under tenant improvement allowance

 

3,669

 

 

 

Conversion of convertible preferred stock to common stock upon initial public offering

 

$

 

$

 

 

6



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