-----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, O+vzCDXUAh2/6mkAvSnSJ0uYk1j4nIw4j9eiDU6+ym2di078/pw0n0SsvpFgkjqZ xLfwbQkNnQiqH0zNek2M2w== 0001104659-08-011465.txt : 20080219 0001104659-08-011465.hdr.sgml : 20080218 20080219151330 ACCESSION NUMBER: 0001104659-08-011465 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20080219 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20080219 DATE AS OF CHANGE: 20080219 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: 08626323 MAIL ADDRESS: STREET 1: 10421 PACIFIC CENTER COURT STREET 2: STE 150 CITY: SAN DIEGO STATE: CA ZIP: 92121 8-K 1 a08-5944_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): February 19, 2008

 

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 February 19, 2008, the registrant issued a press release announcing its financial results for the three months and year ended December 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 February 19, 2008, 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, increases in restricted cash, 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 and year ended December 31, 2007 are as follows (in millions):

 

Actual

 

Three Months Ended
December 31, 2007

 

Year Ended
December 31, 2007

 

 

 

(unaudited)

 

(unaudited)

 

 

 

 

 

 

 

Net cash used in operating activities

 

$

8.5

 

$

37.6

 

Purchase of property and equipment

 

0.6

 

9.6

 

Proceeds from debt

 

 

(6.9

)

Payments on debt

 

1.7

 

6.1

 

Realized premium/discount on short-term investments

 

 

(0.4

)

 

 

 

 

 

 

Cash burn

 

$

10.8

 

$

46.0

 

 

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 February 19, 2008.

 

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: February 19, 2008

Tamara A. Seymour

 

Chief Financial Officer

 

4



 

INDEX TO EXHIBITS

 

99.1     Press release of the registrant dated February 19, 2008.

 

5



 

EX-99.1 2 a08-5944_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 Fourth Quarter and Year End 2007 Financial Results

 

Analysis of Primary Endpoint for Phase 3 Registration Trial No Later Than July 2008

 

San Diego — Feb. 19, 2008 — Favrille, Inc. (Nasdaq: FVRL), a biopharmaceutical company developing patient-specific, active immunotherapies for the treatment of cancer, today reported its financial results for the fourth quarter and year end 2007. For the quarter and year ended December 31, 2007, the Company reported net losses of $7.8 million, or $0.21 per share, and $43.1 million, or $1.28 per share, respectively, compared to $10.2 million, or $0.35 per share, and $40.5 million, or $1.49 per share, for the same periods in 2006.

 

“It is with great excitement and anticipation that we begin 2008 and approach the end of our Phase 3 clinical trial of Specifid™ (mitumprotimut-T, formerly FavId®),” said John P. Longenecker, Ph.D., President and Chief Executive Officer of Favrille. “We are in the process of data collection and are on schedule for data cut off in April and completion of data analysis no later than July. The rate of disease progression continues to be very slow and we believe we have enrolled an optimal patient population to maximize prospects for demonstrating a clinical benefit in our Phase 3 trial.”

 

Fourth Quarter and Year End 2007 Financial Review

 

Research and development expense was approximately $7.8 million and $34.9 million for the fourth quarter and year ended December 31, 2007, respectively, compared to approximately $7.7 million and $31.1 million for the same periods in 2006. The increase is primarily due to operating expenses, including salaries and stock-based compensation, associated with our commercial-scale manufacturing facility, and consulting and outside services to support our Specifid Phase 3 clinical trial. Total stock-based compensation included in research and development expense was approximately $486,000 and $2.2 million for the fourth quarter and year ended December 31, 2007, compared to approximately $580,000 and $2 million for the same periods in 2006.

 

1



 

Marketing, general and administrative expense was approximately $2.4 million and $11.2 million for the fourth quarter and year ended December 31, 2007, respectively, compared to approximately $2.9 million and $11.2 million for the same periods in 2006. The decrease for the quarter is primarily due to savings related to strategic marketing programs and travel-related expense. For the full year, this decrease was offset by increases in salaries and stock-based compensation. Total stock-based compensation included in marketing, general and administrative expense was approximately $569,000 and $2.4 million for the fourth quarter and year ended December 31, 2007, compared to approximately $530,000 and $2 million for the same periods in 2006.

 

The fair value of the warrants issued in connection with Favrille’s registered direct offering of common stock and warrants in November 2007 was recorded as a liability using the Black Sholes valuation model. In accordance with SFAS 133, Accounting for Derivative Instruments and Hedging Activities, the warrants were revalued using Black Sholes at December 31, 2007. The change in valuation resulted in a decrease of $2.3 million in net losses for the quarter and year ended December 31, 2007, compared to the same periods in 2006.

 

As of December 31, 2007, Favrille had cash, cash equivalents and short-term investments of $29.9 million, compared to $42.4 million at December 31, 2006. The decrease is primarily due to net cash used to fund ongoing operations, offset by the $33.5 million in net proceeds from the Company’s registered direct offerings of common stock and warrants in February 2007 and November 2007.

 

“We believe our cash on hand is sufficient to fund operations through the primary endpoint analysis in our Phase 3 clinical registration trial, which we expect no later than July 2008,” said Tamara A. Seymour, Chief Financial Officer of Favrille.

 

Conference Call and Webcast Information

 

Favrille management will host a conference call today to discuss the fourth quarter and year end 2007 financial results at 5:00 p.m. Eastern Time. A live audio webcast of management’s presentation will be available on the Investor Relations section of the Company’s web site at www.favrille.com. Alternatively, callers may participate in the conference call by dialing (888) 713-4213 or (617) 213-4865, passcode 19388148. To pre-register for this call, please go to https://www.theconferencingservice.com/prereg/key.process?key=P9YHNKNHB. Callers who pre-register will be given a unique PIN to gain immediate access to the call and bypass the live operator. You may pre-register at any time, including up to and after the call start time. 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 99385491.

 

About Favrille, Inc.

 

Favrille, Inc. is a biopharmaceutical company focused on the development and commercialization of targeted immunotherapies for the treatment of cancer and other diseases of the immune system. The Company’s lead product candidate, Specifid (mitumprotimut-T, formerly FavId), is based upon unique genetic information extracted from a patient’s tumor.

 

2



 

Specifid is currently under clinical investigation in a Phase 3 registration 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 cutaneous 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 Favrille’s ability to fund operations through the primary endpoint analysis of its Phase 3 clinical registration trial progress and timing of clinical trials for Specifid, including difficulties or delays in development, testing, manufacturing and marketing Specifid 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 Specifid 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 Specifid 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 Specifid for use in clinical trials and, if Specifid receives marketing approval, for commercialization; risks associated with achieving projected operating metrics and financial performance or the anticipated number of patients using Specifid; 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)

 

 

 

December 31,

 

 

 

2007

 

2006

 

 

 

(unaudited)

 

 

 

Assets

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

26,362

 

$

14,249

 

Short-term investments

 

3,577

 

28,160

 

Other current assets

 

806

 

850

 

Total current assets

 

30,745

 

43,259

 

Property and equipment, net

 

33,293

 

25,071

 

Restricted cash

 

3,451

 

3,451

 

Other assets

 

466

 

508

 

Total assets

 

$

67,955

 

$

72,289

 

Liabilities and stockholders’ equity

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable and accrued liabilities

 

$

3,551

 

$

6,779

 

Current portion of debt

 

5,275

 

4,976

 

Warrants liability

 

2,492

 

 

Total current liabilities

 

11,318

 

11,755

 

Debt, less current portion

 

6,342

 

5,754

 

Deferred rent

 

15,415

 

10,145

 

Commitments and contingencies

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

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

 

 

 

Common stock, $0.001 par value 75,000,000 shares authorized; 41,168,432 and 29,060,081 issued and outstanding at December 31, 2007 and 2006, respectively

 

41

 

29

 

Additional paid-in capital

 

233,807

 

200,497

 

Accumulated other comprehensive income

 

7

 

3

 

Deficit accumulated during the development stage

 

(198,975

)

(155,894

)

Total stockholders’ equity

 

34,880

 

44,635

 

Total liabilities and stockholders’ equity

 

$

67,955

 

$

72,289

 

 

4



 

FAVRILLE, INC.

(a development stage company)

STATEMENTS OF OPERATIONS

(in thousands, except share and per share data)

 

 

 

Years ended December 31,

 

Three months ended December 31,

 

 

 

2007

 

2006

 

2007

 

2006

 

 

 

(unaudited)

 

 

 

(unaudited)

 

(unaudited)

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Research & development

 

$

34,864

 

$

31,050

 

$

7,764

 

$

7,680

 

Marketing, general and administrative

 

11,198

 

11,170

 

2,400

 

2,945

 

Total operating expenses

 

46,062

 

42,220

 

10,164

 

10,625

 

Interest income

 

1,786

 

2,648

 

363

 

644

 

Interest expense

 

(1,053

)

(834

)

(281

)

(191

)

Other expense

 

(66

)

(105

)

(66

)

(76

)

Change in valuation of warrants

 

2,314

 

 

2,314

 

 

Total other income (expense), net

 

2,981

 

1,709

 

2,330

 

377

 

Net loss

 

$

(43,081

)

$

(40,511

)

$

(7,834

)

$

(10,248

)

Historical net loss per share:

 

 

 

 

 

 

 

 

 

Basic and diluted

 

$

(1.28

)

$

(1.49

)

$

(0.21

)

$

(0.35

)

Weighted-average shares —

basic and diluted

 

33,581,590

 

27,247,385

 

38,112,063

 

28,931,495

 

 

5



 

FAVRILLE, INC.

(a development stage company)

STATEMENTS OF CASH FLOWS

(in thousands)

 

 

 

Years ended December 31,

 

 

 

2007

 

2006

 

 

 

(unaudited)

 

 

 

Operating activities:

 

 

 

 

 

Net loss

 

$

(43,081

)

$

(40,511

)

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

 

 

 

 

 

Depreciation and amortization

 

3,449

 

2,133

 

Stock-based compensation

 

4,584

 

4,010

 

Amortization of premium/discount on short-term investments

 

(412

)

(638

)

Change in valuation of warrants

 

(2,314

)

 

Other

 

162

 

281

 

Changes in operating assets and liabilities:

 

 

 

 

 

Other assets

 

66

 

105

 

Accounts payable and accrued liabilities

 

(1,557

)

1,072

 

Deferred rent

 

1,452

 

1,443

 

Net cash used in operating activities

 

(37,651

)

(32,105

)

Investing activities:

 

 

 

 

 

Purchases of property and equipment

 

(9,571

)

(8,586

)

Purchases of short-term investments

 

(14,899

)

(63,386

)

Maturities of short-term investments

 

39,898

 

58,348

 

Restricted cash

 

 

(1,901

)

Net cash provided by (used in) investing activities

 

15,428

 

(15,525

)

Financing activities:

 

 

 

 

 

Proceeds from debt

 

6,884

 

7,563

 

Payments on debt

 

(6,092

)

(3,113

)

Issuance of common stock and warrants

 

33,546

 

45,369

 

Repurchase of restricted common stock

 

(2

)

(5

)

Net cash provided by financing activities

 

34,336

 

49,814

 

Net increase in cash and cash equivalents

 

12,113

 

2,184

 

Cash and cash equivalents at beginning of period

 

14,249

 

12,065

 

Cash and cash equivalents at end of period

 

$

26,362

 

$

14,249

 

Supplemental disclosures of cash flow information:

 

 

 

 

 

Cash paid for interest

 

$

1,363

 

$

703

 

Supplemental non-cash activities:

 

 

 

 

 

Capitalized interest recorded as property, plant and equipment

 

$

404

 

$

91

 

Accrued asset acquisitions

 

$

(1,670

)

$

1,819

 

Leasehold improvements acquired under tenant improvement allowance

 

$

3,818

 

$

7,382

 

 

6


 

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