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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 10-Q

 

ý Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange
Act of 1934

 

For the quarterly period ended June 30, 2004

 

OR
 

o Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange
Act of 1934

 

Isolagen, Inc.

(Exact name of registrant as specified in its charter)

 

 

 

 

 

Delaware

 

001-31564

 

87-0458888

(State or other jurisdiction

 

(Commission File Number)

 

(I.R.S. Employer

of incorporation)

 

 

 

Identification No.)

 

 

 

 

 

2500 Wilcrest, 5th Floor

Houston, Texas 77042

(Address of principal executive offices, including zip code)

 

 

 

 

 

(713) 780-4754

(Registrant’s telephone number, including area code)

 

Check whether the issuer: (1) filed all reports required to be filed by Section 13 or 15(d) of the Exchange Act during the past 12 months (or for any shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.  ý Yes o No

 

Check whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Exchange Act.)  o Yes  ý No

 

As of August 9, 2004, issuer had 34,049,816 shares of issued and outstanding common stock, par value $0.001.

 

 



 

 

TABLE OF CONTENTS

 

Part I.

Financial Information

 

 

 

 

Item 1.

Financial Statements

 

 

 

 

 

Consolidated Balance Sheets
June 30, 2004 (unaudited) and December 31, 2003

 

 

 

 

 

Consolidated Statements of Operations
Six months ended June 30, 2004 (unaudited) and June 30, 2003 (unaudited)
and cumulative period from inception to June 30, 2004 (unaudited)

 

 

 

 

 

Three months ended June 30, 2004 (unaudited) and June 30, 2003 (unaudited)

 

 

 

 

 

Consolidated Statements of Shareholders’ Equity
From inception to June 30, 2004 (unaudited)

 

 

 

 

 

Consolidated Statements of Cash Flows
Six months ended June 30, 2004 (unaudited) and June 30, 2003 (unaudited)
and cumulative period from inception to June 30, 2004 (unaudited)

 

 

 

 

 

Notes to Unaudited Consolidated Financial Statements

 

 

 

 

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

 

 

 

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

 

 

 

 

Item 4.

Controls and Procedures

 

 

 

 

Part II.

Other Information

 

 

 

 

Item 2.

Changes in Securities, Use of Proceeds and Issuer Purchases of Equity Securities

 

 

 

 

Item 4.

Submission of Matters To a Vote of Security Holders

 

 

 

 

Item 6.

Exhibits and Reports on Form 8-K

 

 



 

PART I - FINANCIAL INFORMATION

 

ITEM 1. FINANCIAL STATEMENTS

 

Isolagen, Inc.

(A Development Stage Company)

 Consolidated Balance Sheets

 

 

 

June 30,
2004

 

December 31,
2003

 

 

 

(unaudited)

 

 

 

Assets

 

 

 

 

 

 

 

 

 

 

 

Current assets

 

 

 

 

 

Cash and cash equivalents

 

$

66,063,998

 

$

15,935,558

 

Accounts receivable, net of allowance for doubtful accounts

 

848,230

 

207,202

 

Inventory

 

486,318

 

259,695

 

Other receivables

 

194,095

 

91,545

 

Prepaid expenses

 

524,811

 

254,508

 

 

 

 

 

 

 

Total current assets

 

68,117,452

 

16,748,508

 

 

 

 

 

 

 

Property and equipment, net

 

1,843,703

 

2,221,838

 

 

 

 

 

 

 

Intangible assets

 

540,000

 

540,000

 

 

 

 

 

 

 

Other assets

 

764,741

 

134,119

 

 

 

 

 

 

 

Total assets

 

$

71,265,896

 

$

19,644,465

 

 

 

 

 

 

 

Liabilities and Shareholders’ Equity

 

 

 

 

 

 

 

 

 

 

 

Current liabilities

 

 

 

 

 

Accounts payable

 

$

2,063,515

 

$

1,460,478

 

Accrued expenses

 

881,813

 

535,975

 

Deferred revenue

 

1,285,222

 

384,287

 

 

 

 

 

 

 

Total current liabilities

 

4,230,550

 

2,380,740

 

 

 

 

 

 

 

Total liabilities

 

4,230,550

 

2,380,740

 

 

 

 

 

 

 

Commitments and contingencies

 

 

 

 

 

 

 

 

 

 

 

Shareholders’ equity

 

 

 

 

 

Preferred stock, $.001 par value; 5,000,000 shares authorized; no shares issued and outstanding

 

 

 

Common stock, $.001 par value; 50,000,000 shares authorized; 34,021,546 and 26,672,192 shares issued and outstanding, respectively

 

34,022

 

26,672

 

Additional paid-in capital

 

109,329,022

 

50,862,258

 

Other comprehensive income (foreign currency translation)

 

397,950

 

374,380

 

Accumulated deficit during development stage

 

(42,725,648

)

(33,999,585

)

 

 

 

 

 

 

Total shareholders’ equity

 

67,035,346

 

17,263,725

 

 

 

 

 

 

 

Total liabilities and shareholders’ equity

 

$

71,265,896

 

$

19,644,465

 

 

The accompanying notes are an integral part of these statements.

 

1



 

Isolagen, Inc.

(A Development Stage Company)

Consolidated Statements of Operations

(unaudited)

 

 

 





Six Months Ended
June 30,

 

Cumulative
Period from
December 28,
1995 (date of
inception) to
June 30,
2004

 

 

 

2004

 

2003

 

 

 

 

 

 

 

 

 

 

Revenues

 

 

 

 

 

 

 

Sales

 

$

833,603

 

$

79,796

 

$

2,720,397

 

License fees

 

 

 

260,000

 

 

 

 

 

 

 

 

 

Total revenues

 

833,603

 

79,796

 

2,980,397

 

 

 

 

 

 

 

 

 

Cost of sales

 

641,906

 

48,861

 

1,201,324

 

 

 

 

 

 

 

 

 

Gross profit

 

191,697

 

30,935

 

1,779,073

 

 

 

 

 

 

 

 

 

Selling, general and administrative expenses

 

6,975,576

 

3,523,056

 

22,116,992

 

Research and development

 

1,981,805

 

1,204,538

 

9,053,266

 

 

 

 

 

 

 

 

 

Operating loss

 

(8,765,684

)

(4,696,659

)

(29,391,185

)

 

 

 

 

 

 

 

 

Other income (expense)

 

 

 

 

 

 

 

Interest income

 

39,621

 

10,620

 

317,401

 

Other income

 

 

55,663

 

88,084

 

Loss on sale of property and equipment

 

 

 

(414,635

)

Interest expense

 

 

 

(311,628

)

 

 

 

 

 

 

 

 

Net loss

 

$

(8,726,063

)

$

(4,630,376

)

$

(29,711,963

)

 

 

 

 

 

 

 

 

Deemed dividend associated with beneficial conversion of preferred stock

 

 

(1,244,880

)

(11,423,824

)

Preferred stock dividends

 

 

(411,189

)

(1,589,861

)

Net loss attributable to common shareholders

 

$

(8,726,063

)

$

(6,286,445

)

$

(42,725,648

)

 

 

 

 

 

 

 

 

Per share information

 

 

 

 

 

 

 

Net loss – basic and diluted

 

$

(0.32

)

$

(0.30

)

$

(3.69

)

Deemed dividend associated with beneficial conversion of preferred stock

 

 

(0.08

)

(1.42

)

Preferred stock dividends

 

 

(0.03

)

(0.20

)

Net loss attributable to common shareholders – basic and diluted

 

$

(0.32

)

$

(0.41

)

$

(5.31

)

 

 

 

 

 

 

 

 

Weighted average number of basic and diluted common shares outstanding

 

27,350,296

 

15,348,709

 

8,049,756

 

 

The accompanying notes are an integral part of these statements.

 

2



 

 

 

Three Months Ended June 30,

 

 

 

2004

 

2003

 

 

 

 

 

 

 

Revenues

 

$

544,246

 

$

79,425

 

 

 

 

 

 

 

Cost of sales

 

415,001

 

47,867

 

 

 

 

 

 

 

Gross profit

 

129,245

 

31,558

 

 

 

 

 

 

 

Selling, general and administrative expenses

 

3,211,257

 

1,862,566

 

Research and development

 

798,823

 

613,457

 

 

 

 

 

 

 

Operating loss

 

(3,880,835

)

(2,444,465

)

 

 

 

 

 

 

Other income

 

 

 

 

 

Interest income

 

21,516

 

3,190

 

 

 

 

 

 

 

Net loss

 

$

(3,859,319

)

$

(2,441,275

)

 

 

 

 

 

 

Deemed dividend associated with beneficial conversion of preferred stock

 

 

(1,244,880

)

Preferred stock dividends

 

 

(201,450

)

Net loss attributable to common shareholders

 

$

(3,859,319

)

$

(3,887,605

)

 

 

 

 

 

 

Per shares information

 

 

 

 

 

Net loss – basic and diluted

 

$

(0.14

)

$

(0.16

)

Deemed dividend associated with beneficial conversion of preferred stock

 

 

(0.08

)

Preferred stock dividends

 

 

(0.01

)

Net loss attributable to common shareholders – basic and diluted

 

$

(0.14

)

$

(0.25

)

 

 

 

 

 

 

Weighted average number of basic and diluted common shares outstanding

 

27,986,126

 

15,343,047

 

 

3



 

Isolagen, Inc.

(A Development Stage Company)

Consolidated Statements of Shareholders’ Equity

(unaudited)

 

 

 


Series A Preferred Stock

 


Series B Preferred Stock

 


Common Stock

 

Additional
Paid-In
Capital

 

Accumulated
Deficit
During
Development
Stage

 

 

 


Treasury Stock

 

Total
Shareholders’
Equity
(Deficit)

 

Number
of
Shares

 

Amount

Number
of
Shares

 

Amount

Number
of
Shares

 

Amount

Other
Comprehensive
Income

Number
of
Shares

 

Amount

Issuance of common stock for cash on 12/28/95

 

 

$

 

 

$

 

2,285,291

 

$

2,285

 

$

(1,465

)

$

 

$

 

 

$

 

$

820

 

Issuance of common stock for cash on 11/7/96

 

 

 

 

 

11,149

 

11

 

49,989

 

 

 

 

 

50,000

 

Issuance of common stock for cash on 11/29/96

 

 

 

 

 

2,230

 

2

 

9,998

 

 

 

 

 

10,000

 

Issuance of common stock for cash on 12/19/96

 

 

 

 

 

6,690

 

7

 

29,993

 

 

 

 

 

30,000

 

Issuance of common stock for cash on 12/26/96

 

 

 

 

 

11,148

 

11

 

49,989

 

 

 

 

 

50,000

 

Net loss

 

 

 

 

 

 

 

 

(270,468

)

 

 

 

(270,468

)

Balance, 12/31/96

 

 

$

 

 

$

 

2,316,508

 

$

2,316

 

$

138,504

 

$

(270,468

)

$

 

 

$

 

$

(129,648

)

Issuance of common stock for cash on 12/27/97

 

 

 

 

 

21,182

 

21

 

94,979

 

 

 

 

 

95,000

 

Issuance of common stock for Services on 9/1/97

 

 

 

 

 

11,148

 

11

 

36,249

 

 

 

 

 

36,260

 

Issuance of common stock for Services on 12/28/97

 

 

 

 

 

287,193

 

287

 

9,968

 

 

 

 

 

10,255

 

Net loss

 

 

 

 

 

 

 

 

(52,550

)

 

 

 

(52,550

)

Balance, 12/31/97

 

 

$

 

 

$

 

2,636,031

 

$

2,635

 

$

279,700

 

$

(323,018

)

$

 

 

$

 

$

(40,683

)

 

The accompanying notes are an integral part of these statements.

 

4



 

 

 


Series A Preferred Stock

 


Series B Preferred Stock

 


Common Stock

 

Additional
Paid-In
Capital

 

Accumulated
Deficit
During
Development
Stage

 

 

 


Treasury Stock

 

Total
Shareholders’
Equity
(Deficit)

 

Number
of
Shares

 

Amount

Number
of
Shares

 

Amount

Number
of
Shares

 

Amount

Other
Comprehensive
Income

Number
of
Shares

 

Amount

Issuance of common stock for cash on 8/23/98

 

 

$

 

 

$

 

4,459

 

$

4

 

$

20,063

 

$

 

$

 

 

$

 

$

20,067

 

Repurchase of common stock on 9/29/98

 

 

 

 

 

 

 

 

 

 

2,400

 

(50,280

)

(50,280

)

Net loss

 

 

 

 

 

 

 

 

(195,675

)

 

 

 

(195,675

)

Balance, 12/31/98

 

 

$

 

 

$

 

2,640,490

 

$

2,639

 

$

299,763

 

$

(518,693

)

$

 

2,400

 

$

(50,280

)

$

(266,571

)

Issuance of common stock for cash on 9/10/99

 

 

 

 

 

52,506

 

53

 

149,947

 

 

 

 

 

150,000

 

Net loss

 

 

 

 

 

 

 

 

(1,306,778

)

 

 

 

(1,306,778

)

Balance, 12/31/99

 

 

$

 

 

$

 

2,692,996

 

$

2,692

 

$

449,710

 

$

(1,825,471

)

$

 

2,400

 

$

(50,280

)

$

(1,423,349

)

Issuance of common stock for cash on 1/18/00

 

 

 

 

 

53,583

 

54

 

1,869

 

 

 

 

 

1,923

 

Issuance of common stock for Services on 3/1/00

 

 

 

 

 

68,698

 

69

 

(44

)

 

 

 

 

25

 

Issuance of common stock for Services on 4/4/00

 

 

 

 

 

27,768

 

28

 

(18

)

 

 

 

 

10

 

Net loss

 

 

 

 

 

 

 

 

(807,076

)

 

 

 

(807,076

)

Balance, 12/31/00

 

 

$

 

 

$

 

2,843,045

 

$

2,843

 

$

451,517

 

$

(2,632,547

)

$

 

2,400

 

$

(50,280

)

$

(2,228,467

)

 

The accompanying notes are an integral part of these statements.

 

5



 

 

 


Series A Preferred Stock

 


Series B Preferred Stock

 


Common Stock

 

Additional
Paid-In
Capital

 

Accumulated
Deficit
During
Development
Stage

 

 

 


Treasury Stock

 

Total
Shareholders’
Equity
(Deficit)

 

Number
of
Shares

 

Amount

Number
of
Shares

 

Amount

Number
of
Shares

 

Amount

Other
Comprehensive
Income

Number
of
Shares

 

Amount

Issuance of common stock for services on 7/1/01

 

 

$

 

 

$

 

156,960

 

$

157

 

$

(101

)

$

 

$

 

 

$

 

$

56

 

Issuance of common stock for services on 7/1/01

 

 

 

 

 

125,000

 

125

 

(80

)

 

 

 

 

45

 

Issuance of common stock for capitalization of accrued salaries on 8/10/01

 

 

 

 

 

70,000

 

70

 

328,055

 

 

 

 

 

328,125

 

Issuance of common stock for conversion of convertible debt on 8/10/01

 

 

 

 

 

1,750,000

 

1,750

 

1,609,596

 

 

 

 

 

1,611,346

 

Issuance of common stock for conversion of convertible shareholder notes payable on 8/10/01

 

 

 

 

 

208,972

 

209

 

135,458

 

 

 

 

 

135,667

 

Issuance of common stock for bridge financing on 8/10/01

 

 

 

 

 

300,000

 

300

 

(192

)

 

 

 

 

108

 

Retirement of treasury stock on 8/10/01

 

 

 

 

 

 

 

(50,280

)

 

 

(2,400

)

50,280

 

 

Issuance of common stock for net assets of Gemini on 8/10/01

 

 

 

 

 

3,942,400

 

3,942

 

(3,942

)

 

 

 

 

 

Issuance of common stock for net assets of AFH on 8/10/01

 

 

 

 

 

3,899,547

 

3,900

 

(3,900

)

 

 

 

 

 

Issuance of common stock for cash on 8/10/01

 

 

 

 

 

1,346,669

 

1,347

 

2,018,653

 

 

 

 

 

2,020,000

 

Transaction and fund raising expenses on 8/10/01

 

 

 

 

 

 

 

(48,547

)

 

 

 

 

(48,547

)

Issuance of common stock for services on 8/10/01

 

 

 

 

 

60,000

 

60

 

 

 

 

 

 

60

 

Issuance of common stock for cash on 8/28/01

 

 

 

 

 

26,667

 

27

 

39,973

 

 

 

 

 

40,000

 

Issuance of common stock for services on 9/30/01

 

 

 

 

 

314,370

 

314

 

471,241

 

 

 

 

 

471,555

 

 

The accompanying notes are an integral part of these statements.

 

6



 

 

 


Series A Preferred Stock

 


Series B Preferred Stock

 


Common Stock

 

Additional
Paid-In
Capital

 

Accumulated Deficit
During
Development
Stage

 

 

 


Treasury Stock

 

Total
Shareholders’
Equity
(Deficit)

 

Number
of
Shares

 

Amount

Number
of
Shares

 

Amount

Number
of
Shares

 

Amount

Other
Comprehensive
Income

Number
of
Shares

 

Amount

Uncompensated contribution of services - 3rd quarter

 

 

$

 

 

$

 

$

 

$

 

$

55,556

 

$

 

$

 

 

$

 

$

55,556

 

Issuance of common stock for services on 11/1/01

 

 

 

 

 

145,933

 

146

 

218,754

 

 

 

 

 

218,900

 

Uncompensated contribution of services - 4th quarter

 

 

 

 

 

 

 

100,000

 

 

 

 

 

100,000

 

Net loss

 

 

 

 

 

 

 

 

(1,652,004

)

 

 

 

(1,652,004

)

Balance, 12/31/01

 

 

$

 

 

$

 

15,189,563

 

$

15,190

 

$

5,321,761

 

$

(4,284,551

)

$

 

 

$

 

$

1,052,400

 

Uncompensated contribution of services - 1st quarter

 

 

 

 

 

 

 

100,000

 

 

 

 

 

100,000

 

Issuance of preferred stock for cash on 4/26/02

 

905,000

 

905

 

 

 

 

 

2,817,331

 

 

 

 

 

2,818,236

 

Issuance of preferred stock for cash on 5/16/02

 

890,250

 

890

 

 

 

 

 

2,772,239

 

 

 

 

 

2,773,129

 

Issuance of preferred stock for cash on 5/31/02

 

795,000

 

795

 

 

 

 

 

2,473,380

 

 

 

 

 

2,474,175

 

Issuance of preferred stock for cash on 6/28/02

 

229,642

 

230

 

 

 

 

 

712,991

 

 

 

 

 

713,221

 

Uncompensated contribution of services - 2nd quarter

 

 

 

 

 

 

 

100,000

 

 

 

 

 

100,000

 

Issuance of preferred stock for cash on 7/15/02

 

75,108

 

75

 

 

 

 

 

233,886

 

 

 

 

 

233,961

 

Issuance of common stock for cash on 8/1/02

 

 

 

 

 

38,400

 

38

 

57,562

 

 

 

 

 

57,600

 

Issuance of warrants for services on 9/06/02

 

 

 

 

 

 

 

103,388

 

 

 

 

 

103,388

 

Uncompensated contribution of services - 3rd quarter

 

 

 

 

 

 

 

100,000

 

 

 

 

 

100,000

 

Uncompensated contribution of services - 4th quarter

 

 

 

 

 

 

 

100,000

 

 

 

 

 

100,000

 

Issuance of preferred stock for dividends

 

143,507

 

144

 

 

 

 

 

502,517

 

(502,661

)

 

 

 

 

Deemed dividend associated with beneficial conversion of preferred stock

 

 

 

 

 

 

 

10,178,944

 

(10,178,944

)

 

 

 

 

Comprehensive income:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

 

 

 

 

 

 

 

(5,433,055

)

 

 

 

(5,433,055

)

Other comprehensive income, foreign currency translation adjustment

 

 

 

 

 

 

 

 

 

13,875

 

 

 

13,875

 

Comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

 

(5,419,180

)

Balance, 12/31/02

 

3,038,507

 

$

3,039

 

 

$

 

15,227,963

 

$

15,228

 

$

25,573,999

 

$

(20,399,211

)

$

13,875

 

 

$

 

$

5,206,930

 

 

The accompanying notes are an integral part of these statements.

 

7



 

 

 


Series A Preferred Stock

 


Series B Preferred Stock

 


Common Stock

 

 

 

Accumulated
Deficit
During
Development
Stage

 

 

 


Treasury Stock

 

Total
Shareholders’
Equity
(Deficit)

 

Number
of
Shares

 

Amount

Number
of
Shares

 

Amount

Number
of
Shares

 

Amount

Additional
Paid-In
Capital

Other
Comprehensive
Income

Number
of
Shares

 

Amount

Issuance of common stock for cash on 1/7/03

 

 

 

 

 

61,600

 

62

 

92,338

 

 

 

 

 

92,400

 

Issuance of common stock for patent pending acquisition on 3/31/03

 

 

 

 

 

100,000

 

100

 

539,900

 

 

 

 

 

540,000

 

Cancellation of common stock on 3/31/03

 

 

 

 

 

(79,382

)

(79

)

(119,380

)

 

 

 

 

(119,459

)

Uncompensated contribution of services – 1st quarter

 

 

 

 

 

 

 

100,000

 

 

 

 

 

100,000

 

Issuance of preferred stock for cash on 5/9/03

 

 

 

110,250

 

110

 

 

 

2,773,218

 

 

 

 

 

2,773,328

 

Issuance of preferred stock for cash on 5/16/02

 

 

 

45,500

 

46

 

 

 

1,145,704

 

 

 

 

 

1,145,750

 

Conversion of preferred stock into common stock – 2nd qtr

 

(70,954

)

(72

)

 

 

147,062

 

147

 

40,626

 

 

 

 

 

40,701

 

Conversion of warrants into common stock – 2nd qtr

 

 

 

 

 

114,598

 

114

 

(114

)

 

 

 

 

 

Uncompensated contribution of services – 2nd quarter

 

 

 

 

 

 

 

100,000

 

 

 

 

 

100,000

 

Issuance of preferred stock dividends

 

 

 

 

 

 

 

 

(1,087,200

)

 

 

 

(1,087,200

)

Deemed dividend associated with beneficial conversion of preferred stock

 

 

 

 

 

 

 

1,244,880

 

(1,244,880

)

 

 

 

 

Issuance of common stock for cash – 3rd qtr

 

 

 

 

 

202,500

 

202

 

309,798

 

 

 

 

 

310,000

 

Issuance of common stock for cash on 8/27/03

 

 

 

 

 

3,359,331

 

3,359

 

18,452,202

 

 

 

 

 

18,455,561

 

Conversion of preferred stock into common stock – 3rd qtr

 

(2,967,553

)

(2,967

)

(155,750

)

(156

)

7,188,793

 

7,189

 

(82,875

)

 

 

 

 

(78,809

)

Conversion of warrants into Common stock – 3rd qtr

 

 

 

 

 

212,834

 

213

 

(213

)

 

 

 

 

 

Compensation expense on warrants issued to non-employees

 

 

 

 

 

 

 

412,812

 

 

 

 

 

412,812

 

Issuance of common stock for cash – 4th qtr

 

 

 

 

 

136,500

 

137

 

279,363

 

 

 

 

 

279,500

 

Conversion of warrants into Common stock – 4th qtr

 

 

 

 

 

393

 

 

 

 

 

 

 

 

Comprehensive income:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

 

 

 

 

 

 

 

(11,268,294

)

 

 

 

(11,268,294

)

Other comprehensive income, foreign currency translation adjustment

 

 

 

 

 

 

 

 

 

360,505

 

 

 

360,505

 

Comprehensive loss

 

––

 

––

 

––

 

––

 

 

––

 

 

 

––

 

––

 

––

 

(10,907,789

)

Balance, 12/31/03

 

––

 

$

 

––

 

$

––

 

26,672,192

 

$

26,672

 

$

50,862,258

 

$

(33,999,585

)

$

374,380

 

––

 

$

 

$

17,263,725

 

 

The accompanying notes are an integral part of these statements.

 

8



 

 

 


Series A Preferred Stock

 


Series B Preferred Stock

 


Common Stock

 

 

 

Accumulated
Deficit
During
Development
Stage

 

 

 


Treasury Stock

 

Total
Shareholders’
Equity
(Deficit)

 

Number
of
Shares

 

Amount

Number
of
Shares

 

Amount

Number
of
Shares

 

Amount

Additional
Paid-In
Capital

 

 

Other
Comprehensive
Income

 

Number
of
Shares

 

Amount

Conversion of warrants into common stock— 1st qtr

 

 

 

 

 

78,526

 

79

 

(79

)

 

 

 

 

 

Issuance of common stock for cash — 1st qtr

 

 

 

 

 

19,000

 

19

 

102,701

 

 

 

 

 

102,720

 

Compensation expense on options and warrants issued to non-employees and directors — 1st qtr

 

 

 

 

 

 

 

1,410,498

 

 

 

 

 

1,410,498

 

Conversion of warrants into common stock— 2nd qtr

 

 

 

 

 

51,828

 

52

 

(52

)

 

 

 

 

 

Issuance of common stock for cash — 2nd qtr

 

 

 

 

 

7,200,000

 

7,200

 

56,810,234

 

 

 

 

 

56,817,434

 

Compensation expense on options and warrants issued to non-employees and directors — 2nd qtr

 

 

 

 

 

 

 

143,462

 

 

 

 

 

143,462

 

Comprehensive income:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

 

 

 

 

 

 

 

(8,726,063

)

 

 

 

(8,726,063

)

Other comprehensive income, foreign currency translation adjustment

 

 

 

 

 

 

 

 

 

23,570

 

 

 

23,570

 

Comprehensive loss

 

––

 

––

 

––

 

––

 

 

––

 

 

 

––

 

––

 

––

 

(8,702,493

)

Balance, 6/30/04

 

––

 

$

 

––

 

$

––

 

34,021,546

 

$

34,022

 

$

109,329,022

 

$

(42,725,648

)

$

397,950

 

––

 

$

 

$

67,035,346

 

 

The accompanying notes are an integral part of these statements.

 

9



 

Isolagen, Inc.

(A Development Stage Company)

Consolidated Statements of Cash Flows

(unaudited)

 

 

 

Six Months Ended
June 30,

 

Cumulative
Period from
December 28,
1995 (date of
inception) to
June 30,

 

 

 

2004

 

2003

 

2004

 

Cash flows from operating activities

 

 

 

 

 

 

 

Net loss

 

$

(8,726,063

)

$

(4,630,376

)

$

(29,711,963

)

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

 

 

 

 

 

 

 

Stock based compensation and expenses

 

1,553,960

 

 

3,176,555

 

Uncompensated contribution of services

 

 

200,000

 

755,556

 

Depreciation

 

545,459

 

357,077

 

1,548,418

 

Loss on sale of property and equipment

 

 

 

414,635

 

Change in operating assets and liabilities:

 

 

 

 

 

 

 

(Increase) in accounts receivable

 

(653,544

)

(18,973

)

(860,747

)

(Increase) decrease in other receivables

 

(103,550

)

54,572

 

(195,095

)

(Increase) in inventory

 

(229,532

)

(125,378

)

(489,227

)

(Increase) decrease in prepaid expenses

 

(263,463

)

27,655

 

(517,971

)

Increase (decrease) in other assets

 

(393,179

)

92,794

 

(526,407

)

Increase (decrease) in accounts payable

 

609,526

 

(343,232

)

2,070,004

 

Increase in accrued expenses

 

349,339

 

220,519

 

885,314

 

Increase in deferred revenue

 

908,201

 

214,257

 

1,292,489

 

Net cash used in operating activities

 

(6,402,846

)

(3,951,085

)

(22,158,439

)

 

 

 

 

 

 

 

 

Cash flows from investing activities

 

 

 

 

 

 

 

Purchase of property and equipment

 

(440,861

)

(1,045,170

)

(3,970,682

)

Proceeds from the sale of property and equipment

 

 

 

34,300

 

Net cash used in investing activities

 

(440,861

)

(1,045,170

)

(3,936,382

)

 

 

 

 

 

 

 

 

Cash flows from financing activities

 

 

 

 

 

 

 

Proceeds from convertible debt

 

 

 

1,450,000

 

Proceeds from notes payable to shareholders

 

 

 

135,667

 

Proceeds from the issuance of preferred stock

 

 

3,919,078

 

12,931,800

 

Net proceeds from the issuance of common stock

 

56,920,154

 

92,400

 

78,583,025

 

Cash dividends paid on preferred stock

 

 

 

(1,087,200

)

Cash paid for fractional shares of preferred stock

 

 

 

(38,108

)

Merger and acquisition expenses

 

 

 

(48,547

)

Repurchase of common stock

 

 

 

(50,280

)

Net cash provided by financing activities

 

56,920,154

 

4,011,478

 

91,876,357

 

 

 

 

 

 

 

 

 

Effect of exchange rate changes on cash balance

 

51,993

 

32,379

 

282,462

 

Net increase (decrease) in cash and cash equivalents

 

50,128,440

 

(952,398

)

66,063,998

 

Cash and cash equivalents, beginning of period

 

15,935,558

 

4,244,640

 

 

Cash and cash equivalents, end of period

 

$

66,063,998

 

$

3,292,242

 

$

66,063,998

 

 

 

 

 

 

 

 

 

Supplemental disclosures of cash flow information:

 

 

 

 

 

 

 

Cash paid for interest

 

$

 

$

 

$

150,283

 

Deemed dividend associated with beneficial conversion of preferred stock

 

 

1,244,880

 

11,423,824

 

Preferred stock dividend

 

 

411,189

 

1,589,861

 

Uncompensated contribution of services

 

 

200,000

 

755,556

 

Common stock issued for intellectual property

 

 

540,000

 

540,000

 

 

The accompanying notes are an integral part of these statements.

 

10



 

Isolagen, Inc.

(A Development Stage Company)

Notes to Unaudited Consolidated Financial Statements

 

Note 1 -  Basis of Presentation, Business and Organization

 

Isolagen, Inc. f/k/a American Financial Holding, Inc., a Delaware corporation (“Isolagen” or the “Company”) is the parent company of Isolagen Technologies, Inc., a Delaware corporation (“Isolagen Technologies”). Isolagen Technologies is the parent company of Isolagen Europe Limited, a company organized under the laws of the United Kingdom (“Isolagen Europe”). Isolagen Technologies is the parent company of Isolagen Australia Pty Limited, a company organized under the laws of Australia (“Isolagen Australia”). Isolagen Technologies is the parent company of Isolagen International, a company organized under the laws of Switzerland (“Isolagen Switzerland”). The common stock of the Company, par value $0.001 per share, (“Common Stock”) is traded on the American Stock Exchange (“AMEX”) under the symbol “ILE.”

 

Isolagen is a Houston, Texas-based company specializing in the development and commercialization of autologous cellular therapies for soft and hard tissue regeneration. Autologous cellular therapy is the process whereby a patient’s own cells are extracted, allowed to multiply and then injected into the patient for applications such as correction and reduction of the normal effects of aging like wrinkles and nasolabial folds.  The procedure is minimally invasive and non-surgical.

 

In May 1996, the Food and Drug Administration, or FDA, in response to the increasing use of cellular therapy to treat serious illness, released draft regulation for public comment to regulate cellular therapy. In May 1998, this regulation was passed, and in 1999, the FDA notified the Company that the Isolagen Process would require FDA approval as a regulated biologic product. In October 1999, the Company filed an investigational new drug application, or IND, which was accepted by the FDA. In November 1999, the Company’s IND was placed on clinical hold while it established a cGMP facility and standard operating procedures, including quality control release criteria. The clinical hold was released in May 2002.  From June 2002, the Company assembled its management and scientific team and improved its Isolagen Process. These improvements included the introduction of an improved transport medium to extend cell viability, the standardization of the injection technique and the standardization of the Company’s manufacturing and laboratory techniques. The Company commenced clinical trials in January 2003 upon completion of its cGMP facility.

 

On April 7, 2004, the Company submitted a request for a Special Protocol Assessment, or SPA, to the FDA with all the supporting information for its two pivotal Phase III clinical trials for specific dermal applications. In the SPA process, the FDA reviews the design and size of a proposed Phase III program and provides comments regarding the adequacy of the clinical trial design to support a claim of efficacy in an approvable Biologics License Application, or BLA. The FDA’s comments are binding on its review decision, except in limited circumstances, such as when a substantial scientific issue essential to determining the safety and efficacy of a product candidate is identified after the Phase III program commences. In May 2004, the FDA approved the Company’s request for an SPA relating to the design of two pivotal Phase III clinical trials to be conducted by Isolagen in support of registration of the Isolagen Process for the treatment of nasolabial folds and glabellar lines.  The Company believes that the FDA’s action will significantly reduce the risks associated with conducting its pivotal Phase III clinical trials to provide evidence of efficacy and safety sufficient for license application. In July 2004, the Company commenced its Phase III Pivotal Trials. Isolagen will be conducting two identical trials for the treatment of facial wrinkles.  The trials are randomized, double blind and placebo controlled and will be conducted at various sites in the United States.  The trials, which will run simultaneously, each have 100 patients split evenly between treatment group and placebo controlled group.  Efficacy will be measured by a two (2) point improvement on a six (6) point scale, as evaluated by an independent assessor after four (4) months of treatment.

 

The Company’s goal is to become a leading provider of solutions for soft and hard tissue regeneration. The Company currently sells its dermal product in the United Kingdom and Australia. The Company plans to expand sales of its dermal product to other parts of Europe, Asia and the Americas.

 

Through June 30, 2004, the Company has been primarily engaged in developing its initial product technology, recruiting personnel, commencing its UK operations and raising capital. In the course of its development activities, the

 

11



 

Company has sustained losses and expects such losses to continue through at least 2004. The Company will finance its operations primarily through its existing cash and future financing.

 

The Company’s ability to operate profitably under its current business plan is largely contingent upon its success in obtaining further sources of funding, prompt regulatory approval to sell its products and upon its continued expansion. The Company will require additional capital in the future to expand its operations. No assurance can be given that the Company will be able to obtain any such additional capital, either through equity or debt financing, on satisfactory terms or at all. Additionally, no assurance can be given that any such financing, if obtained, will be adequate to meet the Company’s ultimate capital needs and to support the Company’s growth. If adequate capital cannot be obtained on satisfactory terms, the Company’s operations could be negatively impacted.

 

If the Company achieves growth in its operations in the next few years, such growth could place a strain on its management, administrative, operational and financial infrastructure. The Company’s ability to manage its current operations and future growth requires the continued improvement of operational, financial and management controls, reporting systems and procedures. In addition, the Company may find it necessary to hire additional management, financial and sales and marketing personnel to manage the Company’s expanding operations. If the Company is unable to manage this growth effectively and successfully, the Company’s business, operating results and financial condition may be materially adversely affected.

 

As of June 30, 2004, the Company had a cash balance of $66.1 million and net working capital of $63.9 million.   As of August 9, 2004, the Company had a cash balance of approximately $64.5 million.  The Company believes its existing cash and cash equivalents will be adequate to meet its anticipated capital and liquidity requirements until June 30, 2006, assuming no additional future sources of funding and assuming no expansion of the Company. The Company does not have any credit facilities with which to fund ongoing working capital needs, and will be dependent on its cash and cash equivalents to fund operations for the foreseeable future.  The Company’s long-term viability is dependent upon the successful operation of its business and its ability to raise funds within the near future for expansion.

 

Acquisition and merger and basis of presentation

 

On August 10, 2001, Isolagen Technologies consummated a merger with American Financial Holdings, Inc. (“AFH”) and Gemini IX, Inc. (“Gemini”). Pursuant to an Agreement and Plan of Merger, dated August 1, 2001, by and among AFH, ISO Acquisition Corp, a Delaware corporation and wholly-owned subsidiary of AFH (“Merger Sub”), Isolagen Technologies, Gemini, a Delaware corporation, and William J Boss, Jr., Olga Marko and Dennis McGill, stockholders of Isolagen Technologies (the “Merger Agreement”), AFH (i) issued 5,453,977 shares of its common stock, par value $0.001 to acquire, in a privately negotiated transaction, 100% of the issued and outstanding common stock (195,707 shares, par value $0.01, including the shares issued immediately prior to the Merger for the conversion of certain liabilities, as discussed below) of Isolagen Technologies, and (ii) issued 3,942,000 shares of its common stock to acquire 100% of the issued and outstanding common stock of Gemini. Pursuant to the terms of the Merger Agreement, Merger Sub, together with Gemini, merged with and into Isolagen Technologies (the “Merger”), and AFH was the surviving corporation. AFH subsequently changed its name to Isolagen, Inc. on November 13, 2001.

 

Prior to the Merger, Isolagen Technologies had no active business and was seeking funding to begin FDA trials of the Isolagen Process. AFH was a non-operating, public shell company with limited assets. Gemini was a non-operating private company with limited assets and was unaffiliated with AFH.

 

Since AFH and Gemini had no operations and limited assets at the time of the Merger, the merger has been accounted for as a recapitalization of Isolagen Technologies and an issuance of common stock by Isolagen Technologies for the net assets of AFH and Gemini. In the recapitalization, Isolagen Technologies is treated as having affected (i) a 27.8694 for 1 stock split, whereby the 195,707 shares of its common stock outstanding immediately prior to the merger are converted into the 5,453,977 shares of common stock received and held by the Isolagen Technologies stockholders immediately after the merger, and (ii) a change in the par value of its common stock, from $0.01 per share to $0.001 per share. The stock split and change in par value have been reflected in the accompanying consolidated financial statements by retroactively restating all share and per share amounts. The stock issuances are accounted for as the issuance of (i) 3,942,400 shares for the net assets of Gemini, recorded at their book value, and (ii) the issuance of

 

12



 

3,899,547 shares (the number of shares AFH had outstanding immediately prior to the Merger) for the net assets of AFH, recorded at their book value.

 

Immediately prior to and as a condition of the Merger, Isolagen Technologies issued an aggregate of 2,328,972 shares (post split) of its common stock to convert to equity an aggregate of $2,075,246 of liabilities, comprised of (i) accrued salaries of $328,125, (ii) convertible debt and related accrued interest of $1,611,346, (iii) convertible shareholder notes and related accrued interest of $135,667 and (iv) bridge financing costs of $108. Simultaneous with the Merger, the Company sold 1,346,669 shares of restricted common stock to certain accredited investors in a private placement transaction. The consideration paid by such investors for the shares of common stock aggregated $2,020,000 in transactions exempt from the registration requirements of the Securities Act. The net cash proceeds of this private placement were used to fund Isolagen’s research and development projects and the initial FDA trials of the Isolagen Process, to explore the viability of entering foreign markets, to provide working capital and for general corporate purposes.

 

The financial statements presented include Isolagen, Inc. and its wholly-owned subsidiaries. All significant intercompany transactions and balances have been eliminated. Isolagen Technologies was, for accounting purposes, the surviving entity of the Merger, and accordingly for the periods prior to the Merger, the financial statements reflect the financial position, results of operations and cash flows of Isolagen Technologies. The assets, liabilities, operations and cash flows of AFH and Gemini are included in the consolidated financial statements from August 10, 2001 onward.

 

Note 2 -                  Summary of Significant Accounting Policies

 

Interim financial information

 

The financial statements included herein, which have not been audited pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”), reflect all adjustments which, in the opinion of management, are necessary for a fair presentation of financial position, results of operations and cash flows for the interim periods on a basis consistent with the annual audited statements. All such adjustments are of a normal recurring nature. The results of operations for interim periods are not necessarily indicative of the results that may be expected for any other interim period of a full year. Certain information, accounting policies and footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America have been omitted pursuant to such rules and regulation, although the Company believes that the disclosures are adequate to make the information presented not misleading. These financial statements should be read in conjunction with the Company’s audited financial statements included in the Company’s Annual Report on Form 10-K/A for the year ended December 31, 2003 filed with the Securities and Exchange Commission on April 28, 2004.

 

Use of Estimates

 

The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period.  Actual results could differ from those estimates.

 

Statement of cash flows

 

For purposes of the statements of cash flows, the Company considers all highly liquid investments (i.e., investments which, when purchased, have original maturities of three months or less) to be cash equivalents.

 

Concentration of credit risk

 

The Company maintains its cash with a major U.S. domestic bank.  The amounts held in this bank exceed the insured limit of $100,000 from time to time.  The terms of these deposits are on demand to minimize risk.  The Company has not incurred losses related to these deposits.

 

13



 

The Company is subject to risks common to companies in the development stage including, but not limited to, development of new products, development of markets and distribution channels, dependence on key personnel, and the ability to obtain additional capital as needed to fund its product plans.  The Company has a limited operating history and has yet to generate any significant revenues from customers.  To date, the Company has been funded by private debt and equity financings.  The Company’s ultimate success is dependent upon its ability to raise additional capital and to successfully develop and market its products.

 

The products developed by the Company require approvals from the United States FDA or other international regulatory agencies prior to commercial sales.  There can be no assurance that all of the Company’s products will receive the necessary approvals.  If the Company was denied such approvals or such approvals were delayed, it would have a material adverse impact on the Company.

 

Inventory

 

Inventory primarily consists of raw materials used in the Isolagen Process. Inventory is stated at the lower of cost or market and cost is determined by the weighted average method.

 

Property and equipment

 

Property and equipment, consisting primarily of lab equipment, computer equipment, leasehold improvements, and office furniture and fixtures is carried at cost less accumulated depreciation.  Depreciation for financial reporting purposes is provided by the straight-line method over the estimated useful lives of three to five years.  Leasehold improvements are amortized using the straight-line method over the remaining life of the lease.  The cost of repairs and maintenance is charged as an expense as incurred.

 

Loss per share data

 

Basic loss per share is calculated based on the weighted average common shares outstanding during the period, after giving effect to the manner in which the merger was accounted for as described in Note 1.  Diluted earnings per share also gives effect to the dilutive effect of stock options, warrants (calculated based on the treasury stock method) and convertible preferred stock.  The Company does not present diluted earnings per share for years in which it incurred net losses as the effect is antidilutive.

 

At June 30, 2004, options and warrants to purchase 7,144,551 shares of common stock at exercise prices ranging from $1.50 to $11.38 per share were outstanding, but were not included in the computation of diluted earnings per share due to their antidilutive effect.

 

Stock based compensation and expenses

 

The Company accounts for its stock-based compensation under the provisions of Statement of Financial Accounting Standards (“SFAS”) No. 123 “Accounting for Stock Based Compensation.” Under SFAS No. 123, the Company is permitted to either record expenses for stock options and other employee compensation plans based on their fair value at the date of grant or to continue to apply the provisions of Accounting Principles Board Opinion No. 25 “Accounting for Stock Issued to Employees,” (“APB No. 25”), and recognize compensation expense, if any, based on the intrinsic value of the equity instrument at the measurement date.  To the extent the options have cashless exercise provisions, the Company utilizes variable accounting.  The Company has elected to continue following the provisions of APB No. 25. Stock options issued to other than employees or directors are recorded on the basis of their fair value as required by SFAS No. 123.

 

The Company from time to time issues common stock, stock options or common stock warrants to acquire services or goods from non-employees. Common stock, stock options and common stock warrants issued to other than employees or directors are recorded on the basis of their fair value, as required by SFAS No. 123, which is measured as of the date required by EITF Issue 96-18, “Accounting for Equity Instruments That Are Issued to Other Than Employees for Acquiring, or in Conjunction with Selling, Goods or Services”.  In accordance with EITF 96-18, the stock options or common stock warrants are valued using the Black-Scholes model on the basis of the market price of the underlying common stock on the “valuation date”, which for options and warrants related to contracts that

 

14



 

have substantial disincentives to non-performance is the date of the contract, and for all other contracts is the vesting date. Expense related to the options and warrants is recognized on a straight-line basis over the shorter of the period over which services are to be received or the vesting period.  Where expense must be recognized prior to a valuation date, the expense is computed under the Black-Scholes model on the basis of the market price of the underlying common stock at the end of the period, and any subsequent changes in the market price of the underlying common stock up through the valuation date is reflected in the expense recorded in the subsequent period in which that change occurs. See Note 4.

 

In December 2002, the Financial Accounting Standards Board (“FASB”) issued SFAS No. 148, “Accounting for Stock-Based Compensation-Transition and Disclosure”. This statement provides guidance for those companies wishing to voluntarily change to the fair value based method of accounting for stock-based compensation. SFAS No. 148 also amends the disclosure requirements of SFAS No. 123, requiring prominent disclosure in annual and interim financial statements regarding a company’s method for accounting for stock-based employee compensation and the effect of the method on reported results. While Isolagen continues to utilize the disclosure-only provisions of SFAS No. 123, the Company has modified its disclosures to comply with SFAS No. 148.

 

Had compensation costs for the Company’s stock option grants to employees and directors been determined based on the fair value at the grant date consistent with the provisions of SFAS No. 123, the Company’s net loss and net loss per share would have increased to the pro forma amounts indicated below:

 

 

 

Three Months Ended June 30,

 

Six Months Ended June 30,

 

 

 

2004

 

2003

 

2004

 

2003

 

 

 

 

 

 

 

 

 

 

 

Net loss attributable to common shareholders – as reported

 

$

(3,859,319

)

$

(3,887,605

)

$

(8,726,063

)

$

(6,286,445

)

Add: Stock-based employee compensation expense (gain) included in reported net loss, net of related tax effects of $0

 

(109,685

)

 

339,505

 

 

Less: total stock-based employee compensation expense determined under fair value based method for all awards granted to employees, net of related tax effect of $0

 

(974,303

)

(920,445

)

(2,074,386

)

(1,626,662

)

Net loss – pro forma

 

$

(4,943,307

)

$

(4,808,050

)

$

(10,460,944

)

$

(7,913,107

)

 

 

 

 

 

 

 

 

 

 

Net loss per share – as reported

 

 

 

 

 

 

 

 

 

Basic and diluted

 

$

(0.14

)

$

(0.25

)

$

(0.32

)

$

(0.41

)

Net loss per share – pro forma

 

 

 

 

 

 

 

 

 

Basic and diluted

 

$

(0.18

)

$

(0.31

)

$

(0.38

)

$

(0.52

)

 

Income taxes

 

An asset and liability approach is used for financial accounting and reporting for income taxes.  Deferred income taxes arise from temporary differences between income tax and financial reporting and principally relate to recognition of revenue and expenses in different periods for financial and tax accounting purposes and are measured using currently enacted tax rates and laws.  In addition, a deferred tax asset can be generated by net operating loss carryforwards (“NOLs”).  If it is more likely than not that some portion or all of a deferred tax asset will not be realized, a valuation allowance is recognized.

 

Revenue recognition

 

The Company recognizes revenue from product sales when goods are shipped and the risk of loss transfers to the customer. Revenue from licenses and other upfront fees are recognized on a ratable basis over the term of the respective agreement. Milestone payments are recognized upon successful completion of a performance milestone event. Any amounts received in advance of performance are recorded as deferred revenue. The Company recognizes revenue over the period the service is performed in accordance with SEC Staff Accounting Bulletin No. 104, “Revenue Recognition in Financial Statements” (“SAB 104”). SAB 104 requires that four basic criteria must be met before

 

15



 

revenue can be recognized: (1) persuasive evidence of an arrangement exists, (2) delivery has occurred or services rendered, (3) the fee is fixed and determinable, and (4) collectibility is reasonably assured. The Company believes that all of these conditions are met at the time of shipment. Currently, three injections are recommended, although the decision to utilize one, two or three injections is between the attending physician and his/her patient. The amount invoiced is fixed and determinable and only varies among customers depending upon the number of injections requested. There is no performance provision under any arrangement with any doctor and there is no right to refund, or returns for unused injections.

 

Currently the Isolagen Process is delivered through an attending physician to each patient using the Company’s recommended regimen of up to three injections.  The Company believes each injection has stand alone value to the patient. The Company invoices the attending physician upon that physician submitting his or her patient’s tissue sample to the Company, as a result of which the contractual arrangement is between the Company and the medical professional. The amount invoiced varies directly with the number of injections requested. Generally, all orders are paid in advance by the physician and are not refundable. Revenue is deferred until shipment, provided no significant obligations remain, and is recognized in installments corresponding to the number of injections shipped to the attending physician. Due to the short shelf life, each injection is cultured on an as needed basis and shipped prior to the individual injection being administered by the physician. The amount of the revenue deferred represents the fair value of the remaining undelivered injections measured in accordance with Emerging Issues Task Force Issue (“EITF”) 00-21, “Accounting for Revenue Arrangements with Multiple Deliverables,” which addresses the issue of accounting for arrangements that involve the delivery of multiple products or services. Should the physician discontinue the regimen prematurely all remaining deferred revenue is recognized.

 

Intangible assets

 

The Company’s intangible assets represent patent applications which are recorded at cost. The Company has filed applications for patents in connection with technologies being developed. The patent applications and any patents issued as a result of these applications are important to the protection of the Company’s technologies that may result from its research and development efforts. Costs associated with patent applications and maintaining patents are capitalized and will be amortized over the life of the patents. The Company reviews the value recorded for intangibles to assess recoverability from future operations using undiscounted cash flows. Impairments are recognized in operating results to the extent the carrying value exceeds fair value determined based on the net present value of estimated future cash flows.

 

Promotional incentives

 

The Company periodically offers promotional incentives to physicians on a case-by-case basis. Promotional incentives are provided to physicians in the form of “at no charge” Isolagen Treatments and Isolagen Treatments offered at a discount from the suggested price list. The Company does not receive any identifiable benefit from the physicians in exchange for any promotional incentives granted.

 

In accordance with EITF 01-09, “Accounting for Consideration Given by a Vendor to a Customer (Including a Reseller of the Vendor’s Products),” the Company does not record any revenue related to “at no charge” Isolagen Treatments and the estimated cost to provide such treatments is expensed as the time the promotion is granted. The Company records any discounts granted as a reduction in revenue (i.e., net revenue after discount) from that specific transaction.

 

Foreign currency translation

 

The financial position and results of operations of the Company’s foreign subsidiaries are generally determined using the local currency as the functional currency. Assets and liabilities of these subsidiaries are translated at the exchange rate in effect at each period-end. Income statement accounts are translated at the average rate of exchange prevailing during the period. Adjustments arising from the use of differing exchange rates from period to period are included in other comprehensive income in shareholders’ equity. Gains and losses resulting from foreign currency transactions are included in earnings and have not been material in any one period.

 

16



 

Comprehensive income

 

Comprehensive income encompasses all changes in equity other than those with shareholders and consists of net earnings and foreign currency translation adjustments. The Company does not provide for U.S. income taxes on foreign currency translation adjustments since it does not provide for such taxes on undistributed earnings of foreign subsidiaries.

 

Research and development expenses

 

Research and development costs are expensed as incurred and include salaries and benefits, costs paid to third-party contractors to perform research, conduct clinical trials, develop and manufacture drug materials and delivery devices, and a portion of facilities cost. Clinical trial costs are a significant component of research and development expenses and include costs associated with third-party contractors. Invoicing from third-party contractors for services performed can lag several months. The Company accrues the costs of services rendered in connection with third-party contractor activities based on its estimate of management fees, site management and monitoring costs and data management costs. Actual clinical trial costs may differ from estimated clinical trial costs and are adjusted for in the period in which they become known.

 

Shipping and handling costs

 

The Company typically does not charge customers for shipping and handling costs. These costs are included in selling, general and administrative expenses.

 

Advertising cost

 

Advertising costs are expensed as incurred and include the costs of public relations activities in Europe and Australia. These costs are included in selling, general and administrative expenses.

 

Note 3 -                  Commitments and Contingencies

 

On October 9, 1996, the Company was advised by the Division of Enforcement of the Securities and Exchange Commission (the “Commission”) that it is considering recommending that the Commission bring an enforcement action, which could include a civil penalty, against the Company in U.S. District Court for failing to file timely periodic reports in violation of Section 13(a) of the Securities and Exchange Act of 1934 and the rules thereunder.

 

In October 1996, the Company also received a request for the voluntary production of information to the Division of Enforcement of the Commission related to the resignation of Coopers & Lybrand LLP and the termination of Arthur Andersen LLP and the appointment of Jones, Jensen & Company as the Company’s independent public accountants and the reasons therefore.  In addition, the Company was requested to provide certain information respecting its previous sales of securities. The Company cooperated in providing information in response to these inquiries in early 1997.  The Company has not been advised of the outcome of the foregoing, and since 1997 has had no further contact by the Division of Enforcement of the Commission.

 

Note 4 -                  Equity, Stock Plan and Warrants

 

Uncompensated contributed services

 

From the date of the Merger through June 30, 2003, the Company did not pay compensation to certain officers and directors.  Accordingly, the Company has capitalized the estimated fair value of these services.  The uncompensated contributed services totaled $200,000 for the three months ended June 30, 2003.  The Company estimated the value of the contributed services based upon its estimate of their fair market value.  This contribution of services was recorded as an increase to compensation expense and increase in additional paid in capital.

 

17



 

Common Stock

 

During the three months ended March 31, 2004, the Company issued 19,000 shares of common stock for cash totaling $102,720 in connection with the exercise of stock options and issued 78,526 shares of common stock in exchange for cashless exercise of warrants.

 

During the three months ended June 30, 2004, the Company issued a) 7,200,000 shares of common stock for cash totaling $56.8 million in connection with the secondary offering completed in June 2004; and b) 51,828 shares of common stock in exchange for cashless exercise of warrants.  During the three month ended June 30, 2004, there were no shares of common stock issued for cash in connection with the exercise of stock options.

 

2001 Stock Option and Stock Appreciation Rights Plan

 

Effective August 10, 2001, the Company adopted the Isolagen, Inc. 2001 Stock Option and Stock Appreciation Rights Plan (the “Stock Plan”). The Stock Plan is discretionary and allows for an aggregate of up to 5,000,000 shares of the Company’s common stock to be awarded through incentive and non-qualified stock options and stock appreciation rights. The Stock Plan is administered by the Company’s Compensation Committee, who has exclusive discretion to select participants who will receive the awards and to determine the type, size and terms of each award granted.

 

In January 2004, the Company issued under the Stock Plan a total of 300,000 options to purchase its common stock with an exercise price of $6.00 per share to three independent board members.  The options vest over a three year period and expire in January 2014.  Compensation expense for these options of $0.4 million was recorded in the three months ended March 31, 2004 as these options had a cashless exercise provision.  Compensation gain for these options of $0.1 million was recorded in the three months ended June 30, 2004.  The cashless exercise provision for these options were eliminated on May 10, 2004, thus an expense will no longer be recorded subsequent to June 30, 2004.

 

In the second quarter of 2004, the Company issued a total of 260,000 options to purchase its common stock with an exercise price ranging from $8.90 to $11.38 per share to various employees. The options vest over a three year period from the date of grant.  In the second quarter of 2004, the Company issued 30,000 options to purchase its common stock with an exercise price of $9.00 to one independent board member.  The options vest after twelve months from the date of grant.

 

2003 Stock Option and Stock Appreciation Rights Plan

 

On January 29, 2003, the Company’s Board of Directors approved the 2003 Stock Option and Appreciation Rights Plan (the “2003 Stock Plan”). The 2003 Stock Plan is discretionary and allows for an aggregate of up to 2,250,000 shares of the Company’s common stock to be awarded through incentive and non-qualified stock options and stock appreciation rights. The 2003 Stock Plan is administered by the Company’s Compensation Committee, who has exclusive discretion to select participants who will receive the awards and to determine the type, size and terms of each award granted.

 

In January 2004, the Company issued 160,000 options to purchase its common stock with an exercise price of $6.00 per share to a consultant. The options vest over a three year period, subject to certain acceleration clauses. In February 2004, the Company issued 100,000 options to purchase its common stock with an exercise price of $10.49 per share to a consultant.  The options vest over a three year period from the date of grant.

 

In the second quarter of 2004, an employee retired 300,000 options to purchase common stock.

 

Warrants and Options Issued for Services

 

As of June 30, 2004, the Company has outstanding 688,600 warrants and options issued to non-employees under consulting and distribution agreements.  The following sets forth certain information concerning these warrants and options:

 

18



 

 

 

Vested

 

Unvested

 

Warrants and options outstanding

 

354,433

 

334,167

 

Vesting period

 

n/a

 

3 to 36 months

 

Range of exercise prices

 

$1.50 to $10.49

 

$6.00 to $10.49

 

Weighted average exercise price

 

$4.31

 

$7.18

 

Expiration dates

 

2005 to 2012

 

2007 to 2013

 

 

Expense related to these contracts was $1.0 million for the three months ended March 31, 2004 and $0.3 million for the three months ended June 30, 2004.

 

Note 5 -                  Geographical Information

 

The Company operates its business on the basis of a single industry reportable segment. The Company markets its products on a global basis. The Company’s principal markets are the United States, United Kingdom and Australia. While no commercial operations have commenced in the United States, the United States is presented separately as it is the Company’s headquarters.

 

Geographical information concerning the Company’s reportable segments is as follows:

 

 

 

Revenue
Three months ended June 30,

 

Revenue
Six months ended June 30,

 

 

 

2004

 

2003

 

2004

 

2003

 

 

 

 

 

 

 

 

 

 

 

United States

 

$

 

$

 

$

 

$

 

United Kingdom

 

454,616

 

79,425

 

656,295

 

79,796

 

Australia

 

89,630

 

 

177,308

 

 

 

 

$

544,246

 

$

79,425

 

$

833,603

 

$

79,796

 

 

 

 

Property and Equipment, net
As of June 30,

 

 

 

2004

 

2003

 

 

 

 

 

 

 

United States

 

$

509,756

 

$

1,165,033

 

United Kingdom

 

778,084

 

872,395

 

Australia

 

555,863

 

810,579

 

 

 

$

1,843,703

 

$

2,848,007

 

 

 

 

Depreciation
Three months ended June 30,

 

Depreciation
Six months ended June 30,

 

 

 

2004

 

2003

 

2004

 

2003

 

 

 

 

 

 

 

 

 

 

 

United States

 

$

124,598

 

$

113,573

 

$

243,945

 

$

198,429

 

United Kingdom

 

59,304

 

51,218

 

117,558

 

109,750

 

Australia

 

89,007

 

48,898

 

183,956

 

48,898

 

 

 

$

272,909

 

$

213,689

 

$

545,459

 

$

357,077

 

 

 

 

Capital Expenditures
Three months ended June 30,

 

Capital Expenditures
Six months ended June 30,

 

 

 

2004

 

2003

 

2004

 

2003

 

 

 

 

 

 

 

 

 

 

 

United States

 

$

307,339

 

$

76,607

 

$

386,848

 

$

274,551

 

United Kingdom

 

34,640

 

69,680

 

46,953

 

248,873

 

Australia

 

3,826

 

126,760

 

7,060

 

521,746

 

 

 

$

345,805

 

$

273,047

 

$

440,861

 

$

1,045,170

 

 

19



 

ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.

 

The following discussion and analysis should be read in conjunction with our consolidated financial statements, including the notes thereto.

 

Forward-Looking Information

 

This report contains certain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, as well as information relating to Isolagen that is based on management’s exercise of business judgment and assumptions made by and information currently available to management. When used in this document and other documents, releases and reports released by us, the words “anticipate,” “believe,” “estimate,” “expect,” and “intend” and words of similar import, are intended to identify any forward-looking statements. You should not place undue reliance on these forward-looking statements.  These statements reflect our current view of future events and are subject to certain risks and uncertainties as noted below. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, our actual results could differ materially from those anticipated in these forward-looking statements.  Actual events, transactions and results may materially differ from the anticipated events, transactions or results described in such statements. The discovery and development of applications for autologous cellular therapy are subject to substantial risks and uncertainties. There can be no assurance that Isolagen’s trials relating to autologous cellular therapy applications for the treatment of dermal defects or gingival recession can be conducted within the timeframe that Isolagen expects, that such trials will yield positive results, or that additional applications for the commercialization of autologous cellular therapy can be identified and advanced into human clinical trials.  These and other factors, some of which are described below, could cause future results to differ materially from the expectations expressed in this report.    Although we believe that our expectations are based on reasonable assumptions, we can give no assurance that our expectations will materialize. Many factors could cause actual results to differ materially from our forward looking statements.  Several of these factors include, without limitation:

 

                  our ability to develop autologous cellular therapies that have specific applications in cosmetic dermatology, and our ability to explore (and possibly develop) applications for periodontal disease, reconstructive dentistry and other health-related markets;

                  whether our clinical human trials relating to autologous cellular therapy applications for the treatment of dermal defects or gingival recession can be conducted within the timeframe that we expect, whether such trials will yield positive results, or whether additional applications for the commercialization of autologous cellular therapy can be identified by us and advanced into human clinical trials;

                  our ability to provide and deliver any autologous cellular therapies that we may develop, on a basis is that is cost competitive with other therapies, drugs and treatments that may be provided by our competitors;

                  our ability to finance our business;

                  our ability to improve our current pricing model;

                  our ability to decrease our cost of goods sold through the development of our Automated Cell Expansion ("ACE")  System  that permits an automated harvesting process in a closed loop sterile environment, which we believe will eliminate several of the steps and materials involved in our current system and will lead to significant cost reductions in both skilled labor and materials and will enable scalable mass production;

      our ability to complete and integrate the ACE System into our UK operations on a timely basis, which we currently believe will consist of four new manufacturing units and which installation will start during the third quarter of 2004 and be finalized by the first quarter of 2005;

      our ability to service the demand for our dermal product in the United Kingdom, which is highly dependent on our ability to complete and integrate the ACE System;

      our ability to significantly reduce our need for fetal bovine calf serum for culturing cells, which process is in the exploratory phase and which we hope will result in an 80% or  greater reduction in the use of such serum;

                  a stable interest rate market in the world, and specifically the countries we are doing business in or plan to do business in;

                  management’s best estimate on the patient data including patients started and patients completed;

                  a stable currency rate environment in the world, and specifically the countries we are doing business in or plan to do business in;

                  our ability to receive requisite regulatory approvals in the United States, Europe, Asia and the Americas, and our ability to retain the licenses that we have obtained and may obtain; and the absence of adverse regulatory developments in the United States, Europe, Asia and the Americas or any other country where we plan to conduct commercial operations;

 

20



 

                  continued availability of supplies at satisfactory prices;

                  no new entrance of competitive products in our markets;

                  no adverse publicity related to our products or the Company itself;

                  no adverse claims relating to our intellectual property;

                  the adoption of new, or changes in, accounting principles; and/or legal proceedings;

                  our ability to maintain compliance with the AMEX requirements for continued listing of our common stock;

                  the costs inherent with complying with new statutes and regulations applicable to public reporting companies, such as the Sarbanes-Oxley Act of 2002;

                  our ability to efficiently integrate future acquisitions, if any;

                  other new lines of business that we may enter in the future; and

                  other risks referenced from time to time elsewhere in this report and in our filings with the SEC.

 

These factors are not necessarily all of the important factors that could cause actual results of operations to differ materially from those expressed in these forward-looking statements. Other unknown or unpredictable factors also could have material adverse effects on our future results.  We undertake no obligation and do not intend to update, revise or otherwise publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of any unanticipated events. We cannot assure you that projected results will be achieved.

 

GENERAL

 

We specialize in the development and commercialization of autologous cellular technology that has specific applications in cosmetic dermatology and are exploring applications for periodontal disease, reconstructive dentistry and other health-related markets. We are developing our lead product candidate for the correction and reduction of the normal effects of aging, such as wrinkles and nasolabial folds. In March 2004, we announced positive results of our first Phase III clinical trial for our lead product candidate. We initiated two additional pivotal Phase III clinical trials for this product candidate in July 2004. We currently expect to file a Biologics License Application, or BLA, for this product candidate during the first quarter of 2005.  We completed a Phase I clinical trial for our second product candidate for the treatment of periodontal disease in late 2003, and we initiated a Phase II clinical trial in May 2004.  We also have an active investigational new drug application for vocal cord injury.  We are currently in discussions with the FDA regarding our Phase I clinical trial protocol. The FDA has approved the protocol which is currently under review by the IRB (“Institutional Review Board”).  We expect to initiate this trial during the third quarter of 2004.  We are also exploring other opportunities for additional product candidates, including for the treatment of acne scars.

 

Our ability to operate profitably under our current business plan is largely contingent upon our success in obtaining further sources of debt and equity capital, prompt regulatory approval to sell our products, our ability to automate our manufacturing process and upon our continued expansion. We will require additional capital in the future to expand our operations. No assurance can be given that we will be able to obtain any such additional capital, either through equity or debt financing, on satisfactory terms or at all. Additionally, no assurance can be given that any such financing, if obtained, will be adequate to meet our ultimate capital needs and to support our growth. If adequate capital cannot be obtained on satisfactory terms, our operations could be negatively impacted.

 

If we achieve growth in our operations in the next few years, such growth could place a strain on our management, administrative, operational and financial infrastructure. Our ability to manage operations and growth requires the continued improvement of operational, financial and management controls, reporting systems and procedures. In addition, we may find it necessary to hire additional management, financial and sales and marketing personnel to manage our expanding operations. If we are unable to manage this growth effectively and successfully, our business, operating results and financial condition may be materially adversely affected.

 

As of June 30, 2004, the Company had a cash balance of $66.1 million and net working capital of $63.9 million.   As of August 9, 2004, the Company had a cash balance of approximately $64.5 million.  The Company believes its existing cash and cash equivalents will be adequate to meet its anticipated capital and liquidity requirements until June 30, 2006, assuming no additional future sources of funding and assuming no expansion of the Company. The Company does not have any credit facilities with which to fund ongoing working capital needs, and will be dependent on its cash and cash equivalents to fund operations for the foreseeable future.  The Company’s long-term viability is dependent upon the successful operation of its business and its ability to raise funds within the near future for expansion.

 

CRITICAL ACCOUNTING POLICIES

 

The following discussion and analysis of financial condition and results of operations are based upon our consolidated financial statements, which have been prepared in conformity with accounting principles generally accepted in the United States of America. The preparation of these financial statements requires management to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues, expenses and related

 

21



 

disclosures. On an on-going basis, we evaluate our estimates and assumptions, including but not limited to those related to the impairment of long-lived assets (including intangible assets), allowances for doubtful accounts, revenue recognition, certain accrued liabilities and stock based expenses. We base our estimates on historical experience and various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the amount and timing of the recognition of revenues and expenses that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

 

Revenue Recognition:  We recognize revenue from product sales when goods are shipped and the risk of loss transfers to the customer. Revenue from licenses and other up-front fees are recognized on a ratable basis over the term of the respective agreement. Milestone payments are recognized upon successful completion of a performance milestone event. Any amounts received in advance of performance are recorded as deferred revenue. We recognize revenue over the period the service is performed in accordance with SEC Staff Accounting Bulletin No. 104, “Revenue Recognition in Financial Statements” (“SAB 104”). SAB 104 requires that four basic criteria must be met before revenue can be recognized: (1) persuasive evidence of an arrangement exists, (2) delivery has occurred or services rendered, (3) the fee is fixed and determinable, and (4) collectibility is reasonably assured. We believe that all of these conditions are met at the time of shipment. Currently, three injections are recommended, although the decision to utilize one, two or three injections is between the attending physician and his/her patient. The amount invoiced is fixed and determinable and only varies among customers depending upon the number of injections requested. There is no performance provision under any arrangement with any doctor and there is no right to refund, or returns for unused injections.

 

Currently the Isolagen Process is delivered through an attending physician to each patient using our recommended regimen of up to three injections.  We believe each injection has stand alone value to the patient. We invoice the attending physician upon that physician submitting his or her patient’s tissue sample to us; as a result of which the contractual arrangement is between us and the medical professional. The amount invoiced varies directly with the number of injections requested.  Generally, all orders are paid in advance by the physician and are not refundable. Revenue is deferred until shipment, provided no significant obligations remain, and is recognized in installments corresponding to the number of injections shipped to the attending physician. Due to the short shelf life, each injection is cultured on an as needed basis and shipped prior to the individual injection being administered by the physician. The amount of the revenue deferral represents the fair value of the remaining undelivered injections measured in accordance with Emerging Issues Task Force Issue (“EITF”) 00-21, “Accounting for Revenue Arrangements with Multiple Deliverables,” which addresses the issue of accounting for arrangements that involve the delivery of multiple products or services. Should the physician discontinue the regimen prematurely all remaining deferred revenue is recognized.

 

Research and development expenses:  Research and development costs are expensed as incurred and include salaries and benefits, costs paid to third-party contractors to perform research, conduct clinical trials, develop and manufacture drug materials and delivery devices, and a portion of facilities cost. Clinical trial costs are a significant component of research and development expenses and include costs associated with third-party contractors. Invoicing from third-party contractors for services performed can lag several months. We accrue the costs of services rendered in connection with third-party contractor activities based on our estimate of management fees, site management and monitoring costs and data management costs. Actual clinical trial costs may differ from estimated clinical trial costs and are adjusted for in the period in which they become known.

 

Intangible assets:  Our intangible assets represent patent applications which are recorded at cost. We have filed applications for patents in connection with technologies being developed. The patent applications and any patents issued as a result of these applications are important to the protection of our technologies that may result from our research and development efforts. Costs associated with patent applications and maintaining patents are capitalized and will be amortized over the life of the patents. We review the value recorded for intangibles to assess recoverability from future operations using undiscounted cash flows. Impairments are recognized in operating results to the extent the carrying value exceeds fair value determined based on the net present value of estimated future cash flows.

 

Stock based compensation and expenses:  We account for our stock-based compensation under the provisions of Statement of Financial Accounting Standards (“SFAS”) No. 123-”Accounting for Stock Based Compensation.” Under SFAS No. 123, we are permitted to either record expenses for stock options and other employee compensation

 

22



 

plans based on their fair value at the date of grant or to continue to apply the provisions of Accounting Principles Board Opinion No. 25 “Accounting for Stock Issued to Employees,” (“APB No. 25”), and recognize compensation expense, if any, based on the intrinsic value of the equity instrument at the measurement date.  To the extent the options have cashless exercise provisions, we utilize variable accounting.  We have elected to continue following the provisions of APB No. 25.

 

From time to time we issue common stock, stock options or common stock warrants to acquire services or goods from non-employees. Common stock, stock options and common stock warrants issued to other than employees or directors are recorded on the basis of their fair value, as required by SFAS No. 123, which is measured as of the date required by EITF Issue 96-18, “Accounting for Equity Instruments That Are Issued to Other Than Employees for Acquiring, or in Conjunction with Selling, Goods or Services”.  In accordance with EITF 96-18, the stock options or common stock warrants are valued using the Black-Scholes model on the basis of the market price of the underlying common stock on the “valuation date”, which for options and warrants related to contracts that have substantial disincentives to non-performance is the date of the contract, and for all other contracts is the vesting date. Expense related to the options and warrants is recognized on a straight-line basis over the shorter of the period over which services are to be received or the vesting period.  Where expense must be recognized prior to a valuation date, the expense is computed under the Black-Scholes model on the basis of the market price of the underlying common stock at the end of the period, and any subsequent changes in the market price of the underlying common stock up through the valuation date is reflected in the expense recorded in the subsequent period in which that change occurs. As a result, the expense related to contracts that do not contain a substantial disincentive to non-performance will fluctuate from period to period based on changes in the market price of our common stock.  Period to period expense may also fluctuate if we decide to exercise our right to terminate certain contracts before some or all of the options or warrants vest.

 

RESULTS OF OPERATIONS

 

Comparison of the six months ending June 30, 2004 and 2003

 

REVENUES.  Revenues increased $753,807, to $833,603 for the six months ended June 30, 2004 compared to $79,796 for the six months ended June 30, 2003.  The increase in revenues is primarily attributable to the expansion of our operations in the United Kingdom and the commencement of operations in Australia.  Sales for the six months ended June 30, 2004 are net of “at no charge” or discounted Isolagen Treatments provided to physicians as incentives.  Such incentives amounted to $0.4 million during the six months ended June 30, 2004 and we anticipate that the level of such incentives will decline in future periods.

 

The Isolagen Process involves a patient’s physician obtaining an approximately three millimeter punch biopsy from behind the patient’s ear using a local anesthetic. The sample is then packed in a special transport vial that we provide to the physician and is shipped overnight to our laboratory. We invoice the physician upon receipt of the skin sample. Upon arrival at our laboratory, the specimen is initiated into culture. Through a series of plastic flasks and growth media, the fibroblasts within the specimen are cultured into tens of millions of cells over a period of approximately six weeks. The fibroblasts are then harvested and put into a special transport vial. After completion of a series of quality control tests, the cells are released and shipped to the physician’s office overnight. Additional amounts are available for re-injection every two to three weeks. We recognize one-third of the revenue associated with each treatment upon the shipment of the first injection to the patient’s physician, an additional one-third of revenue associated with each treatment is recognized upon shipment of the second injection to the patient’s physician, and the remaining one-third is recognized upon the shipment of the last injection to the patient’s physician.

 

The revenues which we did recognize during the six months ended June 30, 2004 from our United Kingdom and Australian operations were in part reduced by the effects of promotional incentives provided to doctors utilizing the Isolagen Process. We expect to continue providing such promotional incentives to doctors during the introduction phase of the Isolagen Process in the United Kingdom.

 

COST OF SALES.  Costs of sales increased to $641,906 for the six months ended June 30, 2004 compared to $48,861 for the six months ended June 30, 2003.  The increase in cost of sales is the result of the increase in our sales as discussed above.

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SELLING, GENERAL AND ADMINISTRATIVE EXPENSES. Selling, general and administrative expenses increased 98%, or $3,452,520, to $6,975,576 for the six months ended June 30, 2004 compared to $3,523,056 for the six months ended June 30, 2003. The major components of the approximately $3.5 million increase in selling, general and administrative expense are as follows:

 

a) Consulting expense increased by approximately $1.2 million to $1.8 million for the six months ended June 30, 2004 compared to $0.6 million for the six months ended June 30, 2003.  The increase included $1.2 million of stock based expenses related to warrants issued under consulting and distribution agreements, and $0.3 million of stock compensation related to stock options issued to directors.  There were no such stock based expenses in the six months ended June 30, 2003.  The level of the expense recorded for the warrants issued under consulting and distribution contracts can vary from quarter to quarter based on changes in the market price of our common stock.

 

b) Salaries increased by approximately $1.2 million to $1.7 million for the six months ended June 30, 2004 compared to $0.5 million for the six months ended June 30, 2003 due to an increase in our number of employees. The six months ended June 30, 2003 expense included an imputed expense of $200,000 for the fair market value of services provided by certain officers for which they will not be compensated.

 

c) Travel expense decreased by approximately $0.1 million to $0.3 million for the six months ended June 30, 2004 compared to $0.4 million for the six months ended June 30, 2003.

 

d) Promotional expense increased by approximately $0.2 million to $0.5 million for the six months ended June 30, 2004 compared to $0.3 million for the six months ended June 30, 2003 due to increased marketing and promotional efforts related to the expansion of our operations in the United Kingdom.

 

e) Depreciation and amortization increased by approximately $0.1 million to $0.5 million for the six months ended June 30, 2004 compared to $0.4 million for the six months ended June 30, 2003, which increase was based on assets placed into service during 2003 with the commencement of our operations in the United Kingdom and the completion of our U.S. laboratory.

 

RESEARCH AND DEVELOPMENT. Research and development expenses increased by approximately $0.8 million during the six months ended June 30, 2004 to $2.0 million as compared to $1.2 million for the same period of 2003, primarily due to a $0.7 million increase in consulting expenses.  Research and development costs are composed primarily of costs related to our efforts to gain FDA approval for the Isolagen Process for our dermal product candidate in the United States.  These costs include those personnel and laboratory costs related to the current FDA trials and certain consulting costs. In July 2004, we commenced our Phase III Pivotal Trials for our dermal product candidate, which are ongoing.  The total cost of research and development as of June 30, 2004 is $9.1 million.   As of June 30, 2004, we believe at a minimum it will cost $2.2 million to complete the approval process for our dermal product candidate.  That estimate assumes that no further testing requirements for the initial dermal applications are imposed by the FDA, that FDA approval is forthcoming and that FDA approval is received during 2005.  The FDA approval process is extremely complicated and is dependent upon our study protocols and the results of our studies.  In the event that the FDA requires additional studies for dermal applications or requires changes in our study protocols or in the event that the results of the studies are not consistent with our expectations the process will be more expensive and time consuming.  Due to the vagaries of the FDA approval process we are unable to predict what the cost of obtaining approval for the initial dermal applications will be if FDA approval is not forthcoming in 2005.  We have other research projects currently underway. However, research and development costs related to these projects were not material during the 2004 or 2003 periods.

 

INTEREST INCOME. Interest income increased 273%, or $29,001, to $39,621 for the six months ended June 30, 2004 compared to $10,620 for the six months ended June 30, 2003.   The increase in interest income resulted principally from an increase in the amount of cash held in interest bearing accounts.

 

OTHER INCOME.  Other income of $55,663 for the six months ended June 30, 2003 represents gains realized on the sale of certain interest bearing securities denominated in Australian dollars and British pounds held to mitigate a portion of the foreign currency exposure related to our international activity.  As of June 30, 2004, we held no such securities.

 

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NET LOSS. Net loss for the six months ended June 30, 2004 was $8,726,063, as compared to a net loss of $4,630,376 for the six months ended June 30, 2003. This increase in net loss represents the effects of the increases in selling, general and administrative expenses and research and development expenses partially offset by the increase in our sales and gross profit.

 

Comparison of the three months ending June 30, 2004 and 2003

 

REVENUES.  Revenues increased $464,821, to $544,246 for the three months ended June 30, 2004 compared to $79,425 for the three months ended June 30, 2003.  The increase in revenues is primarily attributable to the expansion of our operations in the United Kingdom and the commencement of operations in Australia.  Sales for the three months ended June 30, 2004 are net of “at no charge” or discounted Isolagen Treatments provided to physicians as incentives.  Such incentives amounted to $0.3 million during the three months ended June 30, 2004 and we anticipate that the level of such incentives will decline in future periods.

 

The revenues which we did recognize during the three months ended June 30, 2004 from our United Kingdom operations were in part reduced by the effects of promotional incentives provided to doctors utilizing the Isolagen Process. We expect to continue providing such promotional incentives to doctors during the introduction phase of the Isolagen Process in the United Kingdom.

 

COST OF SALES.  Costs of sales increased to $415,001 for the three months ended June 30, 2004 compared to $47,867 for the three months ended June 30, 2003.  The increase in cost of sales is the result of the increase in our sales as discussed above.

 

SELLING, GENERAL AND ADMINISTRATIVE EXPENSES. Selling, general and administrative expenses increased 72%, or $1,348,691, to $3,211,257 for the three months ended June 30, 2004 compared to $1,862,566 for the three months ended June 30, 2003. The major components of the approximately $1.3 million increase in selling, general and administrative expense are as follows:

 

a) Consulting expense stayed constant at $0.3 million for the three months ended June 30, 2004 compared to $0.3 million for the three months ended June 30, 2003.  Included in the three months ended June 30, 2004 are $0.3 million of stock based expenses related to warrants issued under consulting and distribution agreements, and ($0.1) million of stock compensation related to stock options issued to directors.  There were no such stock based expenses in the quarter ended June 30, 2003.  The level of the expense recorded for the warrants issued under consulting and distribution contracts can vary from quarter to quarter based on changes in the market price of our common stock.

 

b) Salaries increased by approximately $0.8 million to $1.1 million for the three months ended June 30, 2004 compared to $0.3 million for the three months ended June 30, 2003 due to an increase in our number of employees. The three months ended June 30, 2003 expense included an imputed expense of $100,000 for the fair market value of services provided by certain officers for which they will not be compensated.

 

c) Travel expense stayed constant at $0.2 million for the three months ended June 30, 2004 compared to $0.2 million for the three months ended June 30, 2003.

 

d) Promotional expense increased by approximately $0.2 million to $0.3 million for the three months ended June 30, 2004 compared to $0.1 million for the three months ended June 30, 2003 due to increased marketing and promotional efforts related to the expansion of our operations in the United Kingdom.

 

e) Depreciation and amortization increased by approximately $0.1 million to $0.3 million for the three months ended June 30, 2004 compared to $0.2 million for the three months ended June 30, 2003, which increase was based on assets placed into service during 2003 with the commencement of our operations in the United Kingdom and the completion of our U.S. laboratory.

 

RESEARCH AND DEVELOPMENT. Research and development expenses increased by approximately $0.2 million during the three months ended June 30, 2004 to $0.8 million as compared to $0.6 million for the same

 

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period of 2003, primarily due to a $0.2 million increase in consulting expense.  Research and development costs are composed primarily of costs related to our efforts to gain FDA approval for the Isolagen Process for our dermal product candidate in the United States.  These costs include those personnel and laboratory costs related to the current FDA trials and certain consulting costs.  In July 2004, we commenced our Phase III Pivotal Trials for our dermal product candidate, which are ongoing.  We have other research projects currently underway. However, research and development costs related to these projects were not material during the 2004 or 2003 periods.

 

INTEREST INCOME. Interest income increased 574%, or $18,326, to $21,516 for the three months ended June 30, 2004 compared to $3,190 for the three months ended June 30, 2003.   The increase in interest income resulted principally from an increase in the amount of cash held in interest bearing accounts.

 

NET LOSS. Net loss for the three months ended June 30, 2004 was $3,859,319, as compared to a net loss of $2,441,275 for the three months ended June 30, 2003. This increase in net loss represents the effects of the increases in selling, general and administrative expenses and research and development expenses partially offset by the increase in our sales and gross profit.

 

LIQUIDITY AND CAPITAL RESOURCES

 

Operating Activities

 

Cash used in operating activities during the six months ended June 30, 2004, amounted to $6,402,846, as compared to the $3,951,085 of cash used in operating activities during the six months ended June 30, 2003. The increase in the cash used in operations reflects the increases in our expenses, as discussed above.  For both the six month periods ended June 30, 2004 and June 30, 2003 we financed our operating cash flow needs from our cash on hand at the beginning of the periods.  Those cash balances were the result of equity offerings we completed in fiscal 2003 and fiscal 2002.

 

Investing Activities

 

Cash used by investing activities during the six months ended June 30, 2004, amounted to $440,861 as compared to cash used by investing activities of $1,045,170 during the six months ended June 30, 2003.  In both periods the investing activities were the purchases of property and equipment for our laboratories. The purchases were financed from our cash on hand at the beginning of the periods.

 

Financing Activities

 

Cash provided by financing activities was $56,920,154 for the six months ended June 30, 2004, which consisted substantially of the proceeds from the sale of 7,200,000 shares of common stock in a public offering in June 2004 for cash totaling $56,817,434, after deducting the costs and expenses associated with the sale.   Cash provided by financing activities during the six months ended June 30, 2003, amounted to $4,011,478 consisting of $3,919,078 raised from the issuance of preferred stock and $92,400 raised from the issuance of common stock.

 

In May 2003, we sold in a private offering 155,750 shares of Series B Convertible Preferred Stock at an offering price of $28 per share.  Each share of Series B preferred stock was convertible into 8 shares of our common stock at any time after issuance and accrued dividends at 6% per annum payable in cash or additional shares of Series B Preferred Stock. After deducting the costs and expenses associated with the sale, we received cash totaling $3,919,078. In conjunction with the private offering, we issued to the placement agent warrants to purchase 124,600 shares of common stock with an exercise price of $3.50 per share. The warrants are exercisable immediately after grant and expire five years thereafter.  The fair value of the warrants granted to the placement agent, based on the Black-Scholes valuation model is estimated to be $2.77 per warrant.  The value of the warrants granted was offset from the proceeds received from the sale of the Series B Preferred Stock and recorded as additional paid in capital.

 

As stated above, the price of the Series B Preferred Stock sold was $28 per share.  The market value of our common stock sold on the dates that the preferred stock was sold had a range of $4.40 - $4.54 per common share.   In accordance with EITF 00-27 this created a beneficial conversion to the holders of the preferred stock and a deemed dividend to the preferred stockholders totaling $1,244,880 was recorded with a corresponding amount

 

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recorded as additional paid-in capital.  The deemed dividend associated with the beneficial conversion was calculated as the difference between the fair value of the underlying common stock less the proceeds that were received for the Series B Preferred Stock limited to the value of the proceeds received.

 

Working Capital

 

As of June 30, 2004, the Company had a cash balance of $66.1 million and net working capital of $63.9 million.   As of August 9, 2004, the Company had a cash balance of approximately $64.5 million.  The Company believes its existing cash and cash equivalents will be adequate to meet its anticipated capital and liquidity requirements until June 30, 2006, assuming no additional future sources of funding and assuming no expansion of the Company. The Company does not have any credit facilities with which to fund ongoing working capital needs, and will be dependent on its cash and cash equivalents to fund operations for the foreseeable future.  The Company’s long-term viability is dependent upon the successful operation of its business and its ability to raise funds within the near future for expansion.

 

Inflation did not have a significant impact on our results during the six months ended June 30, 2004.

 

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

Our market risk relates to foreign currency transactions and the potential effects of changes in exchange rates.  Such market risks have not changed materially from those described in Item 2 - Management’s Discussion and Analysis of Financial Condition and Results of Operations, in our Annual Report on Form 10-K/A for the year ended December 31, 2003 filed with the SEC on April 28, 2004.

 

ITEM 4. CONTROLS AND PROCEDURES

 

In accordance with Rule 13a-15(b) promulgated under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), our Chief Executive Officer and Chief Financial Officer (the “Certifying Officers”) have conducted evaluations of our disclosure controls and procedures. As defined under Sections 13a-15(e) and 15d-15(e) of the Exchange Act, the term “disclosure controls and procedures” means controls and other procedures of an issuer that are designed to ensure that information required to be disclosed by the issuer in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by an issuer in the reports that it files or submits under the Exchange Act is accumulated and communicated to the issuer’s management, including its principal executive officer or officers and principal financial officer or officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure. The Certifying Officers have reviewed our disclosure controls and procedures and have concluded that those disclosure controls and procedures were effective as of the end of the our most recent fiscal quarter.

 

During our most recent fiscal quarter, there were no changes in our internal control over financial reporting that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

 

PART II - OTHER INFORMATION

 

ITEM 2.  CHANGES IN SECURITIES, USE OF PROCEEDS AND ISSUER PURCHASES OF EQUITY SECURITIES

 

(a)           In April 2004 our Bylaws were amended.  Certain of the amendments modified the rights of the holders of our common stock.  These amendments were as follows: (i) our Bylaws deny stockholders the right to call a special meeting of stockholders; (ii) our Bylaws provide that special meetings of the stockholders may be called only by a majority of the members of our Board of Directors, our Chairman of the Board of Directors, our Chief Executive Officer or our President; (iii) our Bylaws require that all stockholder actions be taken by a vote of the stockholders at an annual or special meeting, and do not permit our stockholders to act by written consent without a meeting; and (iv) our Bylaws provide for an advance notice procedure for stockholder proposals to be brought before an annual meeting of our stockholders, including proposed nominations of persons for election to the Board of Directors.

 

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(b)           n/a

 

(c)           Set forth below is information concerning all issuances of our securities during the fiscal quarter ended March 31, 2004 and the second quarter June 30, 2004, that were not registered under the Securities Act.

 

During the fiscal quarter ended March 31, 2004, we issued 78,526 shares of common stock to accredited investors upon the cash-less exercise of warrants, which were granted in consideration of services related to a private offering of our securities.  The foregoing transactions were completed pursuant to Rule 506 of Regulation D of the Securities Act. No underwriter was utilized in the transactions, and no commissions or other remuneration was paid in connection with the issuances described above.

 

During the second quarter ended June 30, 2004, we issued 51,828 shares of common stock to accredited investors upon the cash-less exercise of warrants, which were granted in consideration of services related to a private offering of our securities.  The foregoing transactions were completed pursuant to Rule 506 of Regulation D of the Securities Act. No underwriter was utilized in the transactions, and no commissions or other remuneration was paid in connection with the issuances described above.

 

(d)           n/a

 

(e)           We made no repurchases of our common stock during the quarter.

 

ITEM 4.  SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS

 

(a)           Our annual meeting of stockholders was commenced on June 10, 2004, adjourned, and reconvened on July 8, 2004.

 

(b)           Steven Morrell and Marshall G. Webb were elected at the annual meeting to serve until our 2007 annual meeting of stockholders or until their successors are duly elected and qualified.  In addition to Messrs. Morrell and Webb, the directors whose terms of office continued after the meeting were: Michael Macaluso, Frank DeLape, Ralph De Martino, and Henry L. Toh.

 

(c)           In addition to the election of directors, a proposal to ratify the appointment of BDO Seidman, LLP as our independent auditor for fiscal year 2004 was approved by our stockholders.  The following table is a tabulation of the final votes for each of the matters presented at the annual meeting:

 

 

 

Affirmative Votes

 

Withheld /
Negative Votes

 

Abstentions

 

Broker Non-Votes

 

Election – Steven Morrell

 

20,178,773

 

121,314

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Election – Marshall G. Webb

 

20,178,828

 

121,259

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Ratification of BDO Seidman

 

20,294,711

 

1,300

 

4,076

 

 

 

 

ITEM 6.  EXHIBITS AND REPORTS ON FORM 8-K

 

(a)           Exhibits

 

EXHIBIT NO.

 

IDENTIFICATION OF EXHIBIT

 

 

 

31.1

 

Certification of Chief Executive Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

 

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31.2

 

Certification of Chief Financial Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

 

 

 

32.1

 

Certification of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

 

 

 

32.2

 

Certification of Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

 

(b)           Reports on Form 8-K

 

During the second quarter for which this report is being filed we furnished the SEC with eight (8) current reports on Form 8-K, each of which reported events under Item 5 of Form 8-K, except the Form 8-K on April 23, 2004, which reported under Item 4, 5 and 7.

 

                  On April 23, 2004, we announced a change in certifying accountant and a change in board membership.

                  On April 28, 2004, we announced a proposed public offering of 7,000,000 shares of the Company’s common stock.

                  On May 12, 2004, we announced the completion of the Phase I Dental Study and the start of the Phase II Dental Study.

                  On May 24, 2004, we announced the U.S. Food and Drug Administration, or FDA, has approved the Company’s request for a Special Protocol Assessment.

                  On June 7, 2004, we announced that the Company’s shareholders meeting scheduled for June 10, 2004 will be adjourned without any action being taken and reconvened on July 8, 2004.

                  On June 10, 2004, we announced the pricing of the Company’s follow-on offering.

                  On June 16, 2004, we announced the exercise of over-allotment in full and completion of stock offering.

                  On June 29, 2004, we announced that the Company was selected for inclusion by the Russell 3000(R) Index when the broad-market index was reconstituted June 25, 2004.

 

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SIGNATURES

 

In accordance with the requirements of the Exchange Act, the registrant caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

 

ISOLAGEN, INC.

 

 

Date: August 12, 2004

By:  /s/ Jeffrey W. Tomz

 

 

Jeffrey W. Tomz, CFO and Secretary

 

(Principal Financial Officer)

 

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