-----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, TA3BR7ppHaI9eyp2/EWX9XKPWD8C6efo5UzKqz++6utxksGMNEjHwlaYOfGnaDYk bS2CGBNcXJ/CpV5+3ZE7BQ== 0001104659-06-053358.txt : 20060810 0001104659-06-053358.hdr.sgml : 20060810 20060810063027 ACCESSION NUMBER: 0001104659-06-053358 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20060810 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20060810 DATE AS OF CHANGE: 20060810 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: 061019460 MAIL ADDRESS: STREET 1: 10421 PACIFIC CENTER COURT STREET 2: STE 150 CITY: SAN DIEGO STATE: CA ZIP: 92121 8-K 1 a06-17540_18k.htm CURRENT REPORT OF MATERIAL EVENTS OR CORPORATE CHANGES

 

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 10, 2006

FAVRILLE, INC.

(Exact Name of Registrant as Specified in Charter)

DELAWARE

 

000-51134

 

33-0892797

(State or Other Jurisdiction

 

(Commission File Number)

 

(I.R.S. Employer

of Incorporation)

 

 

 

Identification No.)

 

 

 

 

 

 

 

10421 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.

August 10, 2006, the registrant issued a press release announcing its financial results for the three and six months ended June 30, 2006.  A copy of the press release and accompanying information is attached as Exhibit 99.1 to this Current Report.

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.

Item 8.01               Other Events.

 

                During the earnings call held on August 10, 2006, 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 and proceeds from debt, all being determined in accordance with GAAP.   Cash burn as 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 that rate at which we are using our total cash and investment balances in our 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 our 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, 2006 are as follows (in millions):

 

Actual

 

 

 

Three months ended
June 30, 2006

 

Six months ended
June 30, 2006

 

 

 

(unaudited)

 

 

 

 

 

 

 

Net cash used in operating activities

 

$

7.9

 

$

15.8

 

Purchases of property and equipment

 

1.6

 

2.6

 

Restricted cash

 

1.9

 

1.9

 

Proceeds from debt

 

(3.0

)

(3.3

)

Payments on debt

 

0.7

 

1.2

 

Cash burn

 

$

9.1

 

$

18.2

 

 

 

Item 9.01.                                          Financial Statements and Exhibits.

(d)                     Exhibits

99.1                         Press release of the registrant dated August 10, 2006.

2




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 10, 2006

 

Tamara A. Seymour

 

 

Chief Financial Officer

 

3




INDEX TO EXHIBITS

99.1               Press release of the registrant dated August 10, 2006.

 

4



EX-99.1 2 a06-17540_1ex99d1.htm EX-99

EXHIBIT 99.1

Company Contacts:

 

Tamara A. Seymour

Pete De Spain

CFO and Vice President,

Associate Director,

Finance & Administration

Investor Relations & Corporate Communications

Favrille, Inc.

Favrille, Inc.

(858) 526-8035

(858) 526-2426

tseymour@favrille.com

pdespain@favrille.com

 

Favrille Reports Second Quarter 2006 Financial Results

San Diego – Aug. 10, 2006 – 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 2006. For the three and six months ended June 30, 2006, the Company reported net losses of $9.8 million, or $0.34 per share, and $20.7 million, or $0.81 per share, respectively, compared to a net loss of $9.4 million, or $0.47 per share, and $17.8 million, or $1.10 per share, for the same periods in 2005.

“We remain confident in the design and execution of our pivotal Phase 3 clinical trial of FavId® and look forward to our analysis of the response improvement data from this trial in the fourth quarter,” John P. Longenecker, Ph.D., President and Chief Executive Officer of Favrille. “Meanwhile, we continue to make progress with the construction of our commercial manufacturing facility in preparation for the launch of FavId, moving another step closer to offering an important treatment option to patients with B-cell non-Hodgkin’s lymphoma (NHL).”

Second Quarter 2006 Financial Review

Research and development expense was approximately $7.5 million and $15.9 million for the three and six months ended June 30, 2006, respectively, compared to approximately $7.9 million and $14.7 million for the same periods in 2005. The decrease in the second quarter of 2006 primarily reflects the reduction of clinical site costs and manufacturing supplies due to the completion of patient enrollment in the Company’s pivotal Phase 3 clinical trial in January 2006. The overall increase for the six months ended June 30, 2006 is primarily due to additional expenses for clinical development of FavId, including personnel and clinical trial site costs. Effective January 1, 2006, Favrille implemented SFAS 123(R). Total stock-based compensation included in research and development was approximately $485,000 and $920,000 for the three and six months ended June 30, 2006, compared to approximately $350,000 and $700,000 for the same periods in 2005.

Marketing, general and administrative expense was approximately $2.9 million and $5.6 million for the three and six months ended June 30, 2006, respectively, compared to approximately $1.7 million and $3.3 million for the same periods in 2005. The increase is primarily due to additional personnel and outside services related to strategic marketing programs and an increase in administrative personnel in preparation for the commercialization of FavId. Total stock-based compensation included in marketing, general and administrative expense was approximately

1




$500,000 and $950,000 for the three and six months ended June 30, 2006, compared to approximately $350,000 and $740,000 for the same periods in 2005.

As of June 30, 2006, Favrille had cash, cash equivalents and short term investments of $61.7 million, compared to $34.5 million at December 31, 2005. The increase is primarily due to the $45.4 million in proceeds, before expenses, from the Company’s private placement of common stock and warrants in March 2006, partially offset by net cash used to fund ongoing operations.

“We continue to expect total operating expenses for the full year 2006 to be in the range of $44 million to $47 million, including an estimated $3 million to $4 million in stock-based compensation,” said Tamara A. Seymour, Chief Financial Officer of Favrille. “Our cash, cash equivalents and short term investments are still expected to be in the range of $37 million to $40 million at the end of 2006.”

Recent Highlights

·                  Long-Term Follow-Up Data from Phase 2 Trial of FavId. In preparation for the upcoming American Society of Hematology Annual Meeting in December, Favrille recently reviewed long-term follow-up data from its Phase 2 clinical trial of FavId following Rituxan® in patients with follicular B-cell NHL. Notably, the data showed an increase in the percentage of patients with a response improvement following initiation of FavId treatment. In addition, a number of patient groups, including patients who were treatment-naïve prior to entering the study, have not reached median time to disease progression (TTP) 32 months from the end of patient enrollment. Favrille believes that these data support the design of its pivotal Phase 3 clinical trial. Approximately 80 percent of the patients enrolled in the Company’s Phase 3 trial are treatment-naïve with the remainder either relapsed from or refractory to prior therapies.

·                  Published Data from Single Agent Trial of FavId. Favrille published data from its Phase 2 clinical trial evaluating FavId as a single therapeutic agent in the July 1st issue of the Journal of Clinical Oncology.  This initial trial served as proof of concept that FavId is well tolerated and demonstrates biologic activity in previously treated and relapsed patients with indolent B-cell NHL. This provided the foundation for subsequent trials of FavId, including the Company’s pivotal Phase 3 trial.

·                  Investigational New Drug (IND) Application for T-Cell Lymphoma. Favrille’s IND application for FAV-201, a patient-specific immunotherapy for the treatment of T-cell lymphoma, was allowed by the U.S. Food & Drug Administration (FDA) in June. FAV-201 will be evaluated initially in cutaneous T-cell lymphoma. This new product candidate is an extension of Favrille’s platform and draws on the Company’s success to date in the development of its lead product candidate FavId for the treatment of B-cell NHL.

·                  Construction of Commercial Manufacturing Facility. Favrille began construction of its commercial manufacturing facility in June. The Company expects that construction of the facility will be funded by landlord improvement allowances and proceeds from a line of

2




credit. The facility will dedicate 80,000 square feet exclusively to manufacturing, with a capacity to produce FavId for up to 4,000 patients per year. Favrille expects the facility to be capable of commercial production of FavId as early as the fourth quarter of 2007.

·                  David Molowa, Ph.D. Appointed to Board of Directors. Dr. Molowa was appointed to Favrille’s Board of Directors in July after spending the last 15 years on Wall Street as a sell-side analyst at UBS Securities, JP Morgan Securities and Bear Stearns & Co. Most recently he was a Managing Director at UBS Securities, leading the firm’s biotechnology research efforts. Previous to his career in the financial industry, Dr. Molowa was a senior research biochemist and lab director for Merck & Co. Favrille believes that he is an ideal complement to the Company’s knowledgeable, industry-oriented Board.

Conference Call and Webcast Information

Favrille management will host a conference call today at 4:30 p.m. Eastern Time to discuss the second quarter 2006 financial results. 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 (800) 561-2718 or (617) 614-3525, passcode 63460381. 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 74137894.

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 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; Favrille’s ability to obtain marketing approval for FavId or Favrille’s other product candidates and the timing of any such approvals, including Favrille’s ability to complete a commercial-scale manufacturing facility without utilizing proceeds from equity offerings; 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

3




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.

4




FAVRILLE, INC.

(a development stage company)

BALANCE SHEETS

(in thousands, except share and per share data)

 

 

 

June 30,
2006

 

December 31,
2005

 

 

 

(unaudited)

 

 

 

Assets

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

28,817

 

$

12,065

 

Short-term investments

 

32,835

 

22,427

 

Receivables

 

351

 

372

 

Prepaid expenses and other current assets

 

737

 

563

 

Total current assets

 

62,740

 

35,427

 

Property and equipment, net

 

10,987

 

9,430

 

Restricted cash

 

3,451

 

1,550

 

Other assets

 

640

 

600

 

Total assets

 

$

77,818

 

$

47,007

 

Liabilities and stockholders’ equity

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable and accrued liabilities

 

$

5,439

 

$

3,888

 

Current portion of debt

 

3,676

 

2,553

 

Total current liabilities

 

9,115

 

6,441

 

Debt, less current portion

 

4,575

 

3,532

 

Deferred rent

 

2,013

 

1,320

 

Commitments and contingencies

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

Preferred stock, $0.001 par value 5,000,000 shares authorized at June 30, 2006 and December 31, 2005; no shares issued and outstanding at June 30, 2006 and December 31, 2005

 

 

 

Common stock, $0.001 par value:

 

 

 

 

 

Authorized shares, 75,000,000 at June 30, 2006 and December 31, 2005;

 

 

 

 

 

Issued and outstanding shares— 28,916,355 and 20,329,046 at June 30, 2006 and December 31, 2005, respectively

 

29

 

20

 

Additional paid-in capital

 

198,164

 

156,882

 

Deferred stock-based compensation

 

 

(5,655

)

Note receivable from stockholder

 

 

(96

)

Accumulated other comprehensive loss

 

(15

)

(54

)

Deficit accumulated during the development stage

 

(136,063

)

(115,383

)

Total stockholders’ equity

 

62,115

 

35,714

 

Total liabilities and stockholders’ equity

 

$

77,818

 

$

47,007

 

 

5




FAVRILLE, INC.
(a development stage company)

STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)

Unaudited

 

 

 

Three Months ended
June 30,

 

Six Months ended
June 30,

 

 

 

2006

 

2005

 

2006

 

2005

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Research and development

 

$

7,462

 

$

7,909

 

$

15,883

 

$

14,737

 

General and administrative

 

2,919

 

1,681

 

5,620

 

3,345

 

Total operating expenses

 

10,381

 

9,590

 

21,503

 

18,082

 

Interest income

 

798

 

409

 

1,231

 

705

 

Interest expense

 

(213

)

(181

)

(379

)

(389

)

Other expense

 

(29

)

(11

)

(29

)

(12

)

Loss on extinguishment of debt

 

 

 

 

 

Total other income, net

 

556

 

217

 

823

 

304

 

Net loss

 

(9,825

)

(9,373

)

(20,680

)

(17,778

)

Deemed dividend-beneficial conversion feature for Series C redeemable convertible preferred stock

 

 

 

 

 

Accretion of Series C redeemable convertible preferred stock issuance costs

 

 

 

 

(6

)

Net loss applicable to common stockholders

 

$

(9,825

)

$

(9,373

)

$

(20,680

)

$

(17,784

)

Historical net loss per share:

 

 

 

 

 

 

 

 

 

Basic and diluted

 

$

(0.34

)

$

(0.47

)

$

(0.81

)

$

(1.10

)

Weighted-average shares-basic and diluted

 

28,708,766

 

19,810,409

 

25,597,762

 

16,118,557

 

 

6




 

FAVRILLE, INC.
(a development stage company)

 

STATEMENTS OF CASH FLOWS
(in thousands)

Unaudited

 

 

 

Six Months ended
June 30,

 

 

 

2006

 

2005

 

 

 

 

 

 

 

Operating activities

 

 

 

 

 

Net loss

 

$

(20,680

)

$

(17,778

)

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

 

 

 

 

 

Depreciation and amortization

 

1,010

 

884

 

Loss on disposal of fixed assets

 

29

 

 

Issuance of options and warrant related to consulting agreements

 

 

 

Stock-based compensation

 

1,864

 

1,454

 

Non-cash interest expense

 

100

 

22

 

Loss on extinguishment of debt

 

 

 

Issuance of restricted common stock for license

 

 

 

Deferred rent

 

693

 

272

 

Amortization of premium/discount on short-term investments

 

(162

)

(3

)

Accrued interest on short-term investments

 

140

 

(21

)

Unrealized loss on cash and cash equivalents

 

 

1

 

Changes in operating assets and liabilities:

 

 

 

 

 

Receivables

 

(119

)

(7

)

Prepaid expenses and other assets

 

(214

)

41

 

Accounts payable and accrued liabilities

 

1,551

 

344

 

Net cash used in operating activities

 

(15,788

)

(14,791

)

Investing activities

 

 

 

 

 

Purchases of property and equipment

 

(2,595

)

(371

)

Purchases of short-term investments

 

(32,055

)

(4,267

)

Maturities of short-term investments

 

21,848

 

 

Other assets

 

 

 

Restricted cash

 

(1,901

)

 

Sale of restricted cash

 

 

 

Net cash used in investing activities

 

(14,703

)

(4,638

)

Financing activities

 

 

 

 

 

Proceeds from debt

 

3,315

 

1,427

 

Payments on debt

 

(1,249

)

(1,237

)

Issuance of preferred stock, net

 

 

 

Proceeds from issuance of convertible promissory note

 

 

 

Issuance of common stock and warrants

 

45,183

 

39,456

 

Repurchase of restricted common stock

 

(6

)

(7

)

Net cash provided by financing activities

 

47,243

 

39,639

 

Net decrease increase in cash and cash equivalents

 

16,752

 

20,210

 

Cash and cash equivalents at beginning of period

 

12,065

 

25,065

 

Cash and cash equivalents at end of period

 

$

28,817

 

$

45,275

 

 

 

 

 

 

 

Supplemental schedule of non-cash investing and financing activities:

 

 

 

 

 

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

 

$

 

$

43,678

 

 

7



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