-----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, QVmmaTwvz4eTNDh6ZXE2Lo4zieG2/6Zf9nKL+bJOGTYbHnIYLT6EqcwVvgW4UjNy gy9B+TWZ+JBG6TkPogVWSQ== 0001104659-07-060880.txt : 20070809 0001104659-07-060880.hdr.sgml : 20070809 20070809155847 ACCESSION NUMBER: 0001104659-07-060880 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20070809 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20070809 DATE AS OF CHANGE: 20070809 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: 071040308 MAIL ADDRESS: STREET 1: 10421 PACIFIC CENTER COURT STREET 2: STE 150 CITY: SAN DIEGO STATE: CA ZIP: 92121 8-K 1 a07-21573_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): August 9, 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 August 9, 2007, the registrant issued a press release announcing its financial results for the three and six months ended June 30, 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 August 9, 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, 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 and six months ended June 30, 2007 are as follows (in millions):

Actual

 

Three Months Ended
June 30, 2007

 

Six Months Ended
June 30, 2007

 

 

 

(unaudited)

 

(unaudited)

 

Net cash used in operating activities

 

$

9.2

 

$

19.3

 

Purchase of property and equipment

 

2.5

 

6.5

 

Proceeds from debt

 

(1.3

)

(5.6

)

Payments on debt

 

1.5

 

2.7

 

Realized premium/discount on short-term investments

 

 

(0.3

)

 

 

 

 

 

 

Cash burn

 

$

11.9

 

$

22.6

 

 

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 August 9, 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: August 9, 2007

 

Tamara A. Seymour

 

 

 

Chief Financial Officer

 

 

4




INDEX TO EXHIBITS

99.1               Press release of the registrant dated August 9, 2007.

5



EX-99.1 2 a07-21573_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 Second Quarter 2007 Financial Results

San Diego — Aug. 9, 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 second quarter of 2007. For the three and six months ended June 30, 2007, the Company reported net losses of $12.4 million, or $0.38 per share, and $22.9 million, or $0.73 per share, respectively, compared to a net loss of $9.8 million, or $0.34 per share, and $20.7 million, or $0.81 per share, for the same periods in 2006.

“The second quarter was highlighted by the expansion of our pipeline through the acquisition of a series of optimized anti-CD20 antibodies,” said John P. Longenecker, Ph.D., President and Chief Executive Officer of Favrille. “The acquisition of these anti-CD20 antibodies is an extension of our commitment to developing next-generation treatment approaches for B-cell non-Hodgkin’s lymphoma (NHL). In addition, we initiated manufacture of FavId in our recently completed commercial-scale manufacturing facility during the quarter and are in the process of validating the facility in preparation for the commercial launch of FavId®.

“Meanwhile, we are approaching the analysis of our primary endpoint, time to disease progression (TTP), in our pivotal Phase 3 clinical trial of FavId,” Dr. Longenecker continued. “We initiated the trial in July 2004 and completed enrollment in January 2006 with 349 patients randomized one-to-one into the trial. According to our Special Protocol Assessment with the Food & Drug Administration, the triggers for this analysis are either a specified number of progressions or a predetermined patient observation time. Our primary focus has been on the pre-specified number of progressions. However, as previously communicated, we have experienced a slowing in the rate of progressions over the past several months. The consequence of this is that we are now evaluating use of the other option, patient observation time, for triggering the analysis. The analysis of our primary endpoint is now projected to occur in the first half of 2008.”

Second Quarter 2007 Financial Review

Research and development expense was approximately $9.6 million and $17.6 million for the three and six months ended June 30, 2007, respectively, compared to approximately $7.5 million and $15.9 million for the same periods in 2006. The increases were primarily due to additional expenses for personnel and stock-based compensation and increases in facility rent and operating costs, supplies and depreciation related to the facility expansion; offset by decreases in expenses associated with the pivotal Phase 3 clinical trial related to the completion of patient enrollment

1




into the trial in January 2006. Total stock-based compensation included in research and development was approximately $610,000 and $1 million for the three and six months ended June 30, 2007, compared to approximately $485,000 and $918,000 for the same periods in 2006.

Marketing, general and administrative expense was approximately $2.9 million and $5.9 million for the three and six months ended June 30, 2007, respectively, compared to approximately $2.9 million and $5.6 million for the same periods in 2006. The increase primarily reflects an increase in compensation costs associated with additional personnel in the Company’s commercial organization and additional stock-based compensation; offset by a decrease in consulting and outside services related to a software implementation project and strategic marketing programs expensed in 2006. Total stock-based compensation included in marketing, general and administrative expense was approximately $594,000 and $1.2 million for the three and six months ended June 30, 2007, compared to approximately $499,000 and $946,000 for the same periods in 2006.

As of June 30, 2007, cash, cash equivalents and short term investments were approximately $30 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 through the first half of 2008.”

Recent Highlights

·      Acquired Optimized Anti-CD20 Antibodies. Favrille acquired a series of optimized anti-CD20 antibodies from Diversa Corporation (now Verenium Corporation) in June. Favrille obtained the panel of anti-CD20 antibodies, which have been optimized using Diversa’s proprietary Human Framework Reassembly™ technology, along with the corresponding patents and an exclusive, royalty-free license to selected pending patents for commercialization of the panel.

·      Announced Data from Phase 2 Clinical Trial of FavId in Europe. Favrille announced interim data from a Phase 2 clinical trial of FavId in patients with indolent B-cell NHL. The data were reported at the Congress of the European Hematology Association in Vienna in June. The Company is encouraged by the preliminary results from this trial, which included patients with various forms of indolent B-cell NHL, as well as by the feasibility of administering a patient-specific active immunotherapy, manufactured in the U.S., in patients in Europe.

·      Reported Status of Phase 2 Clinical Trial of FavId with Maintenance Rituxan. Favrille announced data from a Phase 2 clinical trial of FavId in combination with maintenance Rituxan for the treatment of indolent B-cell NHL. The progress of this trial was reported at the American Society of Clinical Oncology Annual Meeting in Chicago in June. The early data show that concurrent treatment with maintenance Rituxan and FavId is feasible and well

2




tolerated. This is the first clinical trial of an Id-KLH active immunotherapy in combination with a maintenance Rituxan regimen.

Conference Call and Webcast Information

Favrille management will host a conference call today to discuss the second quarter 2007 financial results at 4:30 p.m. Eastern Time. A live audio webcast of management’s presentation will be available at www.favrille.com. Alternatively, callers may participate in the conference call by dialing (800) 322-5044 or (617) 614-4927, passcode 58433289. 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 35651340.

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, 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 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 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, including the conditions to the Company’s ability to access the committed equity financing facility and therefore fund operations through the first half of 2008; 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)

 

 

June 30,
2007

 

December 31,
2006

 

 

 

(unaudited)

 

 

 

Assets

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

16,577

 

$

14,249

 

Short-term investments

 

13,433

 

28,160

 

Receivables

 

219

 

242

 

Prepaid expenses and other current assets

 

1,071

 

608

 

Total current assets

 

31,300

 

43,259

 

Property and equipment, net

 

34,057

 

25,071

 

Restricted cash

 

3,451

 

3,451

 

Other assets

 

492

 

508

 

Total assets

 

$

69,300

 

$

72,289

 

Liabilities and stockholders’ equity

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable and accrued liabilities

 

$

6,692

 

$

6,779

 

Current portion of debt

 

5,890

 

4,976

 

Total current liabilities

 

12,582

 

11,755

 

Debt, less current portion

 

7,870

 

5,754

 

Deferred rent

 

14,713

 

10,145

 

Commitments and contingencies

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

Preferred stock, $0.001 par value 5,000,000 shares authorized at June 30, 2007 and December 31, 2006; no shares issued and outstanding at June 30, 2007 and December 31, 2006

 

 

 

Common stock, $0.001 par value:

 

 

 

 

 

Authorized shares, 75,000,000 at June 30, 2007 and December 31, 2006;

 

 

 

 

 

Issued and outstanding shares— 32,505,002 and 29,060,081 at June 30, 2007 and December 31, 2006, respectively

 

33

 

29

 

Additional paid-in capital

 

212,912

 

200,497

 

Accumulated other comprehensive loss

 

3

 

3

 

Deficit accumulated during the development stage

 

(178,813

)

(155,894

)

Total stockholders’ equity

 

34,135

 

44,635

 

Total liabilities and stockholders’ equity

 

$

69,300

 

$

72,289

 

 

4




FAVRILLE, INC.

(a development stage company)

STATEMENTS OF OPERATIONS

(in thousands, except per share data)

Unaudited

 

 

Three Months ended
June 30,

 

Six Months ended
June 30,

 

 

 

2007

 

2006

 

2007

 

2006

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Research and development

 

$

9,623

 

$

7,462

 

$

17,620

 

$

15,883

 

General and administrative

 

2,948

 

2,919

 

5,860

 

5,620

 

Total operating expenses

 

12,571

 

10,381

 

23,480

 

21,503

 

Interest income

 

497

 

798

 

1,062

 

1,231

 

Interest expense

 

(314

)

(213

)

(501

)

(379

)

Other expense

 

 

(29

)

 

(29

)

Total other income, net

 

183

 

556

 

561

 

823

 

Net loss applicable to common stockholders

 

$

(12,388

)

$

(9,825

)

$

(22,919

)

$

(20,680

)

Historical net loss per share:

 

 

 

 

 

 

 

 

 

Basic and diluted

 

$

(0.38

)

$

(0.34

)

$

(0.73

)

$

(0.81

)

Weighted-average shares-basic and diluted

 

32,434,847

 

28,708,766

 

31,598,037

 

25,597,762

 

 

5




FAVRILLE, INC.

(a development stage company)

STATEMENTS OF CASH FLOWS

(in thousands)

Unaudited

 

 

Six Months ended

 

 

 

June 30,

 

 

 

2007

 

2006

 

Operating activities

 

 

 

 

 

Net loss

 

$

(22,919

)

$

(20,680

)

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

 

 

 

 

 

Depreciation and amortization

 

1,484

 

1,010

 

Stock-based compensation

 

2,259

 

1,864

 

Amortization of premium/discount on short-term investments

 

(334

)

(162

)

Other

 

64

 

269

 

Changes in operating assets and liabilities:

 

 

 

 

 

Other assets

 

(435

)

(333

)

Accounts payable and accrued liabilities

 

(317

)

1,551

 

Deferred rent

 

873

 

693

 

Net cash used in operating activities

 

(19,325

)

(15,788

)

Investing activities

 

 

 

 

 

Purchases of property and equipment

 

(6,535

)

(2,595

)

Purchases of short-term investments

 

(11,337

)

(32,055

)

Maturities of short-term investments

 

26,400

 

21,848

 

Restricted cash

 

 

(1,901

)

Net cash provided by (used in) investing activities

 

8,528

 

(14,703

)

Financing activities

 

 

 

 

 

Proceeds from debt

 

5,623

 

3315

 

Payments on debt

 

(2,659

)

(1,249

)

Issuance of common stock and warrants

 

10,161

 

45,183

 

Repurchase of restricted common stock

 

 

(6

)

Net cash provided by financing activities

 

13,125

 

47,243

 

Net increase in cash and cash equivalents

 

2,328

 

16,752

 

Cash and cash equivalents at beginning of period

 

14,249

 

12,065

 

Cash and cash equivalents at end of period

 

$

16,577

 

$

28,817

 

 

 

 

 

 

 

Supplemental schedule of non-cash investing and financing activities:

 

 

 

 

 

Capitalized interest recorded as property, plant and equipment

 

$

231

 

$

 

Accrued property and equipment acquisitions

 

$

232

 

$

 

Leasehold improvements acquired under tenant improvement allowance

 

$

3,696

 

$

 

 

6



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