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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934.

 

For the Quarterly Period Ended June 30, 2004

 

Commission File Number 0-18044

 

PROCYTE CORPORATION

(Exact name of the registrant as specified in its charter)

 

Washington

 

91-1307460

(State of incorporation)

 

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

 

 

 

8511 154th Avenue N.E., Redmond, WA

 

98052

(Address of principal executive offices)

 

(Zip code)

 

 

 

Registrant’s telephone number, including area code:

 

(425) 869-1239

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such 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.

 

Yes ý                                                                                     No o

 

Indicate by check mark whether the registrant is an accelerated filer (as defined in Exchange Act Rule 12b-2).

 

Yes o                                                                                     No ý

 

As of July 31, 2004, there were issued and outstanding 15,807,171 shares of common stock, par value $.01 per share.

 

 



 

ProCyte Corporation

 

Index

 

Part I - Financial Information

 

Item 1. Condensed Consolidated Financial Statements (unaudited)

 

Balance Sheets - as of June 30, 2004 and December 31, 2003 (unaudited)

 

Statements of Operations - Three and Six Months Ended June 30, 2004 and 2003 (unaudited)

 

Statements of Cash Flows - Six Months Ended June 30, 2004 and 2003 (unaudited)

 

Statements of Stockholders’ Equity - Six Months Ended June 30, 2004 (unaudited)

 

Notes to Condensed Consolidated Financial Statements (unaudited)

 

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 4.  Submission of Matters to a Vote of Security Holders

 

Item 6.  Exhibits and Reports on Form 8-K

 

Signatures

 

 

 

2



 

Part I - Financial Information

 

Item 1. Condensed Consolidated Financial Statements (unaudited)

 

Balance Sheets - as of June 30, 2004 and December 31, 2003 (unaudited)

(in thousands)

 

 

 

June 30,
2004

 

December 31,
2003

 

ASSETS

 

 

 

 

 

Current Assets

 

 

 

 

 

Cash and cash equivalents

 

$

5,729

 

$

3,796

 

Accounts receivable, net of allowance for doubtful accounts

 

1,202

 

1,336

 

Inventory

 

2,625

 

2,942

 

Prepaid and other

 

217

 

289

 

Total current assets

 

9,773

 

8,363

 

 

 

 

 

 

 

Property and equipment

 

 

 

 

 

Equipment

 

325

 

315

 

Leasehold improvements

 

3,226

 

3,520

 

Less accumulated depreciation and amortization

 

(3,380

)

(3,294

)

Property and equipment, net

 

171

 

541

 

 

 

 

 

 

 

Intangible assets

 

3,205

 

3,212

 

Note due from related party, net

 

781

 

781

 

Deferred tax asset

 

7,055

 

7,068

 

Other assets

 

38

 

38

 

Total Assets

 

$

21,023

 

$

20,003

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

Current Liabilities

 

 

 

 

 

Accounts payable, trade

 

$

631

 

$

147

 

Accrued salaries and benefits

 

310

 

246

 

Other accrued liabilities

 

195

 

239

 

Deferred revenue

 

527

 

60

 

Total current liabilities

 

1,663

 

692

 

Other liabilities

 

93

 

93

 

Total Liabilities

 

1,756

 

785

 

Stockholders’ Equity

 

 

 

 

 

Common stock and additional paid-in-capital

 

85,440

 

85,419

 

Deferred compensation

 

(52

)

(59

)

Accumulated deficit

 

(66,121

)

(66,142

)

Stockholders’ Equity

 

19,267

 

19,218

 

Total Liabilities and Stockholders’ Equity

 

$

21,023

 

$

20,003

 

 

See notes to condensed consolidated financial statements

 

3



 

Statements of Operations - Three and Six Months Ended June 30, 2004 and 2003 (unaudited)

(in thousands, except per share amounts)

 

 

 

Three months ended
June 30,

 

Six months ended
June 30,

 

 

 

2004

 

2003

 

2004

 

2003

 

Revenues

 

 

 

 

 

 

 

 

 

Product sales

 

$

3,454

 

$

2,313

 

$

6,315

 

$

5,195

 

Licenses and royalties

 

230

 

319

 

589

 

783

 

Total revenues

 

3,684

 

2,632

 

6,904

 

5,978

 

Cost of product sales

 

1,157

 

619

 

2,018

 

1,802

 

Gross profit

 

2,527

 

2,013

 

4,886

 

4,176

 

 

 

 

 

 

 

 

 

 

 

Operating Expenses

 

 

 

 

 

 

 

 

 

Marketing and selling

 

1,260

 

814

 

2,458

 

2,213

 

Research, general, and administrative

 

1,057

 

967

 

2,148

 

1,934

 

Loss on asset impairment

 

294

 

 

294

 

 

Total operating expenses

 

2,611

 

1,781

 

4,900

 

4,147

 

Operating income (loss)

 

(84

)

232

 

(14

)

29

 

Interest and other income

 

43

 

37

 

50

 

125

 

Net income (loss) before tax

 

(41

)

269

 

36

 

154

 

Provision (benefit) for income tax

 

(12

)

 

15

 

18

 

Net income (loss)

 

$

(29

)

$

269

 

$

21

 

$

136

 

 

 

 

 

 

 

 

 

 

 

Net earnings per share

 

 

 

 

 

 

 

 

 

Basic

 

$

0.00

 

$

0.02

 

$

0.00

 

$

0.01

 

Diluted

 

$

0.00

 

$

0.02

 

$

0.00

 

$

0.01

 

 

 

 

 

 

 

 

 

 

 

Shares used in per share computation

 

 

 

 

 

 

 

 

 

Basic

 

15,798

 

15,765

 

15,795

 

15,755

 

Diluted

 

15,798

 

16,040

 

16,030

 

15,979

 

 

See notes to condensed consolidated financial statements

 

4



 

Statements of Cash Flows – Six Months Ended June 30, 2004 and 2003 (unaudited)

(in thousands)

 

 

 

Six months ended June 30,

 

 

 

2004

 

2003

 

Operating Activities

 

 

 

 

 

Net income

 

$

21

 

$

136

 

Adjustments to reconcile net income to net cash provided by (used in) operating activities:

 

 

 

 

 

Depreciation and amortization

 

100

 

153

 

Amortization of deferred proceeds

 

 

(134

)

Non-cash expense related to stock-based compensation

 

18

 

24

 

Amortization of promissory note discount

 

 

(16

)

Change in deferred tax asset, net of change in valuation allowance

 

13

 

 

Amortization of deferred compensation

 

10

 

4

 

Loss on asset impairment

 

294

 

 

 

 

 

 

 

 

Change in operating assets and liabilities:

 

 

 

 

 

Accounts receivable

 

134

 

152

 

Inventory

 

310

 

(385

)

Prepaid and other

 

72

 

171

 

Accounts payable, trade

 

484

 

48

 

Accrued salaries and benefits

 

64

 

(126

)

Other accrued liabilities

 

(44

)

(64

)

Deferred revenue

 

467

 

(2

)

Other liabilities

 

 

2

 

Net cash provided by (used in) operating activities

 

1,943

 

(37

)

 

 

 

 

 

 

Financing Activities

 

 

 

 

 

Proceeds from issuance of common stock

 

 

10

 

 

 

 

 

 

 

Investing Activities

 

 

 

 

 

Purchase of property and equipment

 

(10

)

(47

)

Net increase (decrease) in cash and cash equivalents

 

1,933

 

(74

)

 

 

 

 

 

 

Cash and Cash Equivalents

 

 

 

 

 

At beginning of period

 

3,796

 

4,556

 

At end of period

 

$

5,729

 

$

4,482

 

 

See notes to condensed consolidated financial statements

 

5



 

Statements of Stockholders’ Equity - Six Months Ended June 30, 2004 (unaudited)

(in thousands)

 

 

 

Common Stock

 

Additional
Paid-in

 

Deferred
Compen-

 

Accumulated

 

 

 

 

 

Shares

 

Par Value

 

Capital

 

sation

 

Deficit

 

Total

 

Balance, December 31, 2003

 

15,783

 

$

158

 

$

85,261

 

$

(59

)

$

(66,142

)

$

19,218

 

Shares issued under non-employee director stock plan

 

16

 

(*

)

18

 

 

 

18

 

Re-measurement of stock options granted to non-employees

 

 

 

3

 

(3

)

 

 

Amortization of deferred compensation

 

 

 

 

10

 

 

10

 

Net income

 

 

 

 

 

21

 

21

 

Balance, June 30, 2004

 

15,799

 

$

158

 

$

85,282

 

$

(52

)

$

(66,121

)

$

19,267

 

 

This statement contains rounding, and (*) is placed where the number rounds to less than $1,000.

 

See notes to condensed consolidated financial statements

 

6



 

ProCyte Corporation

Notes to Condensed Consolidated Financial Statements (unaudited)

 

1.              Basis of Presentation

 

The accompanying condensed consolidated financial statements (unaudited) include the accounts of ProCyte Corporation and its wholly-owned subsidiaries, NextDerm, Inc. (a Delaware corporation) and NextDerm, Inc. (a Washington corporation) (collectively “ProCyte” or the “Company”), for the three and six month periods ended June 30, 2004 and 2003, and have been prepared by the Company in accordance with accounting principles generally accepted in the United States of America for interim financial information and the instructions to Form 10-Q and Article 10 of Regulation S-X.  Pursuant to such rules and regulations, the condensed consolidated financial statements do not include all of the information and footnotes required by accounting principles generally accepted in the United States of America for audited financial statements.  Accordingly, this financial information should be read in conjunction with the complete audited financial statements, including the notes thereto, which are included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2003.  In the opinion of management, all material adjustments (consisting of normal recurring accruals) considered necessary for a fair presentation of the financial statements have been included.  Interim results are not necessarily indicative of the results that may be expected for the year.

 

Use of Estimates in Financial Statements

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 revenues and expenses during the reporting period and the reported amounts of assets and liabilities and disclosure of contingent liabilities at the date of the financial statements, particularly with respect to the valuation of inventory, notes receivable, goodwill, leasehold improvements and deferred tax assets.  Actual results could differ from those estimates.

 

Stock Based Compensation

The Company follows the intrinsic value based accounting method for stock options contained in APB Opinion No. 25, Accounting for Stock Issued to Employees, as permitted by SFAS No. 123, Accounting for Stock-Based Compensation.  Under this method, no compensation expense has been recognized for employee incentive stock options, as the exercise price of options granted equaled the fair value on the date of grant.

 

The following table represents what the Company’s pro forma amounts of net income (loss) and net income (loss) per share would have been for the three and six months ended June 30, 2004 and 2003, had compensation expense for the Company’s stock options granted under the incentive compensation plan been recognized based upon the fair value of the awards granted.

 

7



 

 

 

(in thousands, except per share amounts)

 

 

 

Three months ended June 30,

 

Six months ended June 30,

 

 

 

2004

 

2003

 

2004

 

2003

 

Net income (loss), as reported

 

$

(29

)

$

269

 

$

21

 

$

136

 

Stock option-based compensation (expense) benefit determined under fair value-based method

 

(63

)

(90

)

11

 

(217

)

Pro forma net income (loss)

 

$

(92

)

$

179

 

$

32

 

$

(81

)

Earnings per share:

 

 

 

 

 

 

 

 

 

As reported basic

 

$

0.00

 

$

0.02

 

$

0.00

 

$

0.01

 

As reported diluted

 

$

0.00

 

$

0.02

 

$

0.00

 

$

0.01

 

Pro forma basic

 

$

(0.01

)

$

0.01

 

$

0.00

 

$

(0.01

)

Pro forma diluted

 

$

(0.01

)

$

0.01

 

$

0.00

 

$

(0.01

)

 

The Company determined the fair value of stock options granted during the three and six months ended June 30, 2004 and 2003 using the Black-Scholes option pricing model and the following assumptions:

 

 

 

Three months ended June 30,

 

Six months ended June 30,

 

Options Granted

 

2004

 

2003

 

2004

 

2003

 

Risk-free interest rate

 

2.49

%

2.58%-2.69

%

2.44%-2.61

%

2.58%-2.81

%

Expected option life (years)

 

6.00

 

6.00

 

6.00

 

6.00

 

Dividend yield

 

0.00

 

0.00

 

0.00

 

0.00

 

Expected volatility

 

63

%

59%-62

%

62%-63

%

59%-62

%

 

2.              Accounts Receivable

 

Two customers represented greater than 10% of the net accounts receivable balance at June 30, 2004 and December 31, 2003 as follows:

 

 

 

June 30, 2004

 

December 31, 2003

 

Customer A

 

26

%

46

%

Customer B

 

14

%

 

Customer C

 

7

%

12

%

 

The Company provided an allowance for uncollectible receivables in the amount of $11,000 and $102,000 at June 30, 2004 and December 31, 2003, respective1y.  The bad debt expense, net of recoveries of $133,000 in 2004 and $3,000 in 2003, was a benefit of $187,000 and an expense of $19,000 for the three months ended June 30, 2004 and 2003, respectively.  The bad debt expense, net of recoveries of $134,000 in 2004 and $5,000 in 2003, was a benefit of $211,000 and an expense of $29,000 for the six months ended June 30, 2004 and 2003, respectively.  Accounts written off to the allowance amounted to $12,000 and $1,000 for the three-month periods ended June 30, 2004 and 2003, respectively.  Accounts written off to the allowance account amounted to $13,000 and $13,000 for the six-month periods ended June 30, 2004 and 2003, respectively.

 

8



 

3.              Inventory

 

Inventory consisted of the following:

 

 

 

(in thousands)

 

 

 

June 30, 2004

 

December 31, 2003

 

Finished Goods

 

$

2,074

 

$

2,235

 

Work in process

 

333

 

406

 

Raw materials

 

218

 

301

 

Total

 

$

2,625

 

$

2,942

 

 

4.              Intangible Assets

 

Intangible assets consisted of the following:

 

 

 

(in thousands)

 

 

 

June 30, 2004

 

December 31, 2003

 

Patents, net of amortization

 

$

61

 

$

70

 

Other intangibles, net of amortization

 

30

 

36

 

Goodwill

 

3,114

 

3,106

 

Intangible Assets, net

 

$

3,205

 

$

3,212

 

 

Patents are shown net of accumulated amortization of $229,000 and $221,000, at June 30, 2004 and December 31, 2003, respectively.  Patents are amortized over the term of the patent and the amortization expense related thereto was $4,000 for each of the three-month periods ended June 30, 2004 and 2003, respectively and $8,000 for each of the six-month periods ended June 30, 2004 and 2003, respectively.  Patent amortization expense is expected to be $16,000 for each of the years ending December 31, 2004 through 2007 and $6,000 for the year ending December 31, 2008.

 

Other intangible assets are shown net of accumulated amortization of $6,000 at June 30, 2004.  The assets consist of trademarks and a customer list acquired from Annette Hanson, Inc. on December 30, 2003.  The trademarks and customer list are being amortized over their expected lives and the amortization expense related thereto was $3,000 and $6,000 for the three and six months periods ended June 30, 2004, respectively. The amortization expense is expected to be $12,000 for each of the years ending December 31, 2004 through 2006.

 

Intangible assets also include goodwill of $3.1 million at June 30, 2004 and December 31, 2003.  The Company determined that it has one reporting unit, therefore, all of the goodwill is deemed to be associated with ProCyte’s overall business operations.

 

5.              Federal and State Income Taxes

 

Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. As of June 30, 2004 and December 31, 2003, a partial valuation reserve for tax benefits of net operating losses and a full valuation reserve for research and development tax credit carry forwards remains in place due to the uncertainty of realizing the full tax benefits of the net operating losses and tax credits as a result of their expiration.  The net changes in the valuation allowance during the six months ended

 

9



 

June 30, 2004, and the year ended December 31, 2003, were a reduction of $33,000 and $7.9 million, respectively.

 

As of June 30, 2004, the Company’s U.S. federal net operating loss and general business credit carry forward for income tax purposes were approximately $67.4 million and $1.6 million, respectively.  If not utilized, the federal net operating loss carry forward and tax credit carry forwards will expire between 2005 and 2021 as follows:

 

 

 

(in thousands)

 

 

 

Net operating
loss

 

General business
credits

 

2005

 

$

2,002

 

$

178

 

2006

 

3,928

 

133

 

2007

 

5,173

 

158

 

2008

 

7,912

 

242

 

Thereafter

 

48,422

 

865

 

Total

 

$

67,437

 

$

1,576

 

 

Future changes in ownership, as defined by Section 382 of the IRC, may limit the amount of net operating loss carry forward used in any one year.

 

6.              Earnings per share

 

Basic and diluted per share results for all periods presented were computed based on the net earnings for the respective periods.  The weighted average number of common shares outstanding during the period was used in the calculation of basic earnings per share.  In accordance with FAS 128, “Earnings Per Share,” the weighted average number of common shares used in the calculation of diluted per share amounts is adjusted for the dilutive effects of stock options based on the treasury stock method only if an entity records earnings from operations, as such adjustments would otherwise be anti-dilutive to earnings per share from operations.  For the three months ended June 30, 2003, 275,342 dilutive stock options were included in the calculation of the average number of common shares outstanding for diluted computations.  For the three month periods ended June 30, 2004 and 2003, options and warrants to purchase 2,595,124 shares and 982,508 shares of common stock, respectively, were not included in the computation of diluted earnings per share because the effect would have been anti-dilutive either because the exercise prices were greater than the average fair market value of the Company’s common stock for the period of $1.10 and $1.16, respectively, or there was a net loss for the period.  For the six months ended June 30, 2004 and 2003, 235,096 and 223,502 dilutive stock options, respectively, were included in the calculation of the average number of common shares outstanding for diluted computations. For the six months ended June 30, 2004 and 2003, options to purchase 1,600,134 shares and 982,508 shares, respectively, of common stock with exercise prices greater than the average fair market value of the Company’s common stock for the period of $1.14 and $1.21, respectively, were not included in the computation of diluted earnings per share because the effect would have been anti-dilutive.

 

7.              Stock Options

 

The Company has stock option plans for directors, officers, employees and consultants that provide for grants of nonqualified and incentive stock options.  Options generally are granted at fair market value, expire between five and ten years from grant date and vest ratably over one to three years.

 

10



 

The following table summarizes information about stock option activity in six-month periods ended June 30, 2004 and 2003:

 

 

 

2004

 

2003

 

Items

 

Number of
Options

 

Wtd. Avg.
Exercise
Price

 

Number of
Options

 

Wtd. Avg.
Exercise
Price

 

Outstanding, beginning of year

 

2,570,167

 

$

1.41

 

2,185,335

 

$

1.57

 

Granted

 

142,000

 

$

1.11

 

167,500

 

$

1.30

 

Exercised

 

 

$

 

(12,000

)

$

0.86

 

Canceled or expired

 

(127,833

)

$

1.59

 

(85,001

)

$

3.76

 

Outstanding, June 30,

 

2,584,334

 

$

1.38

 

2,255,834

 

$

1.47

 

Exercisable, June 30,

 

1,859,515

 

$

1.47

 

1,639,514

 

$

1.52

 

 

The options outstanding at June 30, 2004 consisted of the following:

 

Range of exercise prices

 

Number of
Options
Outstanding

 

Wtd. Avg.
Remaining
Life

 

Wtd. Avg.
Exercise
Price

 

Number of
Options
Exercisable

 

Wtd. Avg.
Exercise
Price

 

$ 0.49 - $0.77

 

564,000

 

5.57

 

$

0.74

 

564,000

 

$

0.74

 

$ 0.77 - $1.09

 

517,500

 

8.29

 

$

1.02

 

135,000

 

$

0.94

 

$ 1.11 - $1.30

 

581,000

 

7.41

 

$

1.23

 

360,171

 

$

1.25

 

$ 1.31 - $1.83

 

538,334

 

6.81

 

$

1.57

 

416,844

 

$

1.59

 

$ 2.16 - $3.44

 

383,500

 

1.64

 

$

2.78

 

383,500

 

$

2.78

 

$ 0.49 - $3.44

 

2,584,334

 

6.20

 

$

1.38

 

1,859,515

 

$

1.47

 

 

The weighted average fair value of options granted during the three-month periods ended June 30, 2004 and 2003 was approximately $0.49 and $0.74, respectively.  The weighted average fair value of options granted during the six months ended June 30, 2004 and 2003 were approximately $0.49 and $0.77, respectively.

 

On April 12, 2004, the Board of Directors adopted the ProCyte Corporation 2004 Stock Option Plan subject to stockholder approval, which approval was obtained on May 19, 2004.  2,000,000 shares of common stock have been reserved for the plan, which provides for the grant of nonqualified and incentive stock options.  At June 30, 2004 there were 53,328 shares reserved for issuance under the Company’s 1996 Stock Option Plan.

 

8.              Related Party Disclosures

 

The Company holds a promissory note in the principal amount of $2 million from Emerald Pharmaceutical L.P. (“Emerald”), received as partial consideration for the sale of its contract manufacturing operations in 2001.  Emerald is in default of its obligations under this promissory note and, at June 30, 2004, such note is recorded net of a valuation allowance of $1.2 million taken in December 2003.  The note is secured by a security agreement covering substantially all of the assets of Emerald and requires Emerald to make monthly interest-only payments equal to the effective yield on the 10 Year US Treasury Note, adjusted quarterly.  The Company also received a minority limited partnership interest in Emerald as part of the consideration received in the sale.  As part of the agreement, ProCyte subleased a portion of its current 34,532 square foot leased facility, including existing leasehold improvements, to Emerald.

 

11



 

Until Emerald suspended operations in February 2004, ProCyte engaged Emerald to manufacture copper peptide compounds, and to perform incoming quality testing and other analytical services.  Emerald billed ProCyte a total of $382,000 for the three-month period ended June 30, 2003, and $19,000 and $1.2 million for the six months ended June 30, 2004 and 2003, respectively, for such products and services.  Emerald provided no products or services during the three months ended June 30, 2004. ProCyte has other sources for these products and services at prices that do not materially differ from those charged by Emerald.  ProCyte had no trade payables to Emerald at June 30, 2004 and December 31, 2003.

 

One of the Company’s Directors also serves as Chairman and Chief Executive Officer of one of ProCyte’s customers.  ProCyte’s sales to the customer were $243,000 and $157,000 for the three month periods ended June 30, 2004 and 2003, respectively and $396,000 and $344,000 for the six month periods ended June 30, 2004 and 2003, respectively.  The customer’s trade receivable balances were $80,000 and $165,000 on June 30, 2004 and December 31, 2003, respectively.

 

An Officer owed the Company $104,000 under a promissory note dated June 30, 2002.  The note bore interest at 2.91%, due annually, with the principal and accrued interest being all due and payable at June 30, 2004.  The note was repaid pursuant to its terms.

 

9.              Loss on Asset Impairment

 

In February 2004, the General Partner of Emerald informed the Company that Emerald had suspended operations and terminated all employees in an effort to conserve remaining capital while it sought other entities to operate or purchase the facility.  Emerald was not successful in returning to operations and, therefore, ProCyte terminated the facility sublease effective June 25, 2004.  In addition, effective July 16, 2004, ProCyte, as a secured party, completed a strict foreclosure process of accepting substantially all of Emerald’s assets in satisfaction of Emerald’s obligations under the $2 million promissory note.  The Company is currently in negotiations to sell substantially all the assets it accepted under the strict foreclosure process to a third party.  The proposed sale is contingent upon entering into a binding definitive asset purchase agreement and the successful negotiation of new leases under terms acceptable to both ProCyte and the proposed buyer.  Based upon the information known at this time, including management’s assessment of the probability of completing the sale and considering the estimated fair value of the assets received, ProCyte has taken an impairment charge of $294,000 at June 30, 2004.

 

10.       Subsequent Event

 

On July 7, 2004 the Company received $166,761 representing full settlement of a judgment obtained in July 2003 against Osmotics Corporation for product and royalty receivables from 2000.  The bad debt recovery and interest earned is included in the Company’s statement of operations for the second quarter of 2004.

 

12



 

Item 2.  Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

This Quarterly Report on Form 10-Q contains forward-looking statements. These statements relate to future events or future financial performance.  In some cases you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expect,” “plan,” “intend,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “propose” or “continue,” the negative of these terms, or other terminology.  These statements are only predictions.  Actual events or results may differ materially.  In evaluating these statements, you should specifically consider various factors described below in the section entitled “Additional Information About the Company’s Business; Risk Factors.” These factors may cause our actual results to differ materially from any forward-looking statement.

 

Although we believe the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, product demand, performance or achievements.  You should not place undue reliance on our forward-looking statements, which speak only as of the date of this report. We undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.

 

Recent Events

 

On June 25, 2004, the Company terminated its facility sublease with Emerald Pharmaceutical, L.P. (“Emerald”).  On July 16, 2004, the Company, as a secured party, completed the strict foreclosure process of accepting substantially all of Emerald’s assets in satisfaction of Emerald’s obligations under the $2 million promissory note.  The Company currently is in negotiations to sell substantially all the assets it accepted under the strict foreclosure process.  The sale is contingent upon entering into a binding definitive asset purchase agreement with the buyer and the successful negotiation of new leases with the landlord, under terms acceptable to both ProCyte and the prospective buyer.  Based upon the information known at this time, including management’s assessment of the probability of completing the sale and considering the estimated fair value of the assets received, ProCyte has taken an impairment charge of $294,000 at June 30, 2004.

 

On June 30, 2004 the company received $106,520 from John F. Clifford in full payment of the outstanding principal and accrued interest pursuant to the terms of a promissory note dated June 30, 2002.

 

On July 7, 2004 the Company received $166,761 representing full settlement of a judgment obtained in July 2003 against Osmotics Corporation for invoices and royalties due the Company from 2000.  The bad debt recovery and interest earned is included in the Company’s statement of operations for the second quarter of 2004.

 

Critical Accounting Policies and Estimates

 

The “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” as well as disclosures included elsewhere in this Form 10-Q, are based upon our condensed consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States of America.  The preparation of these consolidated financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingencies.  On an ongoing basis, we evaluate the estimates used, including those related to impairment and useful lives of intangible assets, allowances for accounts receivable and notes receivable, and for excess and obsolete inventory.  We base our estimates on historical experience, current conditions and on various other assumptions that are believed to be

 

13



 

reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources as well as identifying and assessing our accounting treatment with respect to commitments and contingencies.  Actual results may differ from these estimates under different assumptions or conditions.  We believe the following critical accounting policies involve the more significant judgments and estimates used in the preparation of the consolidated financial statements.

 

Under the guidance of SFAS 109, “Accounting for Income Taxes,” we review our net deferred tax assets to determine which amounts, if any, are “more likely than not” to be utilized in future periods.  Our analysis of whether these tax assets will be utilized involved a substantial amount of judgment related to our ability to generate taxable net income in future periods, including revenue trends, product mix, and estimated margins, the amount and timing of which impacts the amount of net operating tax losses that could be utilized prior to their expiration. 

 

Product revenues are recognized when products are shipped, license fees are recognized over the term of the license agreement, and royalties are recognized when earned.  On occasion, we will receive advance deposits with customer purchase orders.  These deposits are reported as a deferred revenue liability, until the product is shipped to the customer.

 

Under the guidance of SFAS 142, “Goodwill and Other Intangible Assets,” we analyze whether the fair value of recorded goodwill is impaired on an annual basis.  Application of the goodwill impairment test requires judgment, including the identification of reporting units and determining the fair value of each reporting unit.  Significant judgments required to estimate the fair value of the reporting unit include estimating future cash flows, determining appropriate discount rates and other assumptions. Changes in these estimates and assumptions could materially affect the determination of fair value.

 

We maintain an allowance for doubtful accounts for estimated losses resulting from the potential inability of our customers or other debtors to make required payments.  The allowance is based upon historical experience and a review of individual customer balances.  If the financial condition of our customers or other debtors were to deteriorate, resulting in an impairment of their ability to make payments to us, additional allowances may be required.

 

Inventories are stated at the lower of cost or market value.  Cost is principally determined by the first-in, first-out method.  We record adjustments to the value of inventory based upon forecasted plans to sell our inventories.  The physical condition (e.g., age and quality) of the inventories is also considered in establishing its valuation.  These adjustments are estimates, which could vary significantly, either favorably or unfavorably, from the amounts that we may ultimately realize upon the disposition of inventories, if future economic conditions, customer inventory levels, product discontinuances or competitive conditions differ from our estimates and expectations.

 

We record impairment losses on long-lived assets used in operations when events and circumstances indicate that assets might be impaired and the undiscounted cash flows estimated to be generated by those assets are less than the carrying amount of those assets.  Estimation of future values for the long-lived assets requires a significant amount of judgment related to assessing the possible outcomes and the timing related to each outcome.  The adjustments are estimates, which could vary significantly, either favorably or unfavorably, from the amounts that we may ultimately realize for these assets if the actual events differ significantly from our estimates and expectations.

 

14



 

Results of Operations

 

Three Months Ended June 30, 2004 and 2003

 

Revenue

 

 

 

(in thousands)

 

 

 

 

 

Three Months Ended June 30,

 

 

 

 

 

2004

 

2003

 

% Change

 

Products

 

$

2,730

 

$

2,021

 

35

%

Copper peptide compound

 

724

 

292

 

148

%

Royalties

 

230

 

319

 

(28

)%

 

 

$

3,684

 

$

2,632

 

40

%

 

Product revenues for the second quarter of 2004 increased $709,000, or 35 percent over the second quarter of 2003.  The increase was primarily due to a 31 percent increase in sales to physicians and the additional sales related to the spa distribution business included in the 2004 second quarter.  In addition, product revenues in the second quarter of 2003 had been impacted by the slowdown in patient traffic experienced by our dermatology, plastic and cosmetic surgery customers at the beginning of the 2003 year.  Product revenues began recovering during the second half of 2003, in part reflecting certain actions taken such as changing our hiring profile for sales representatives, increasing sales training and expanding customer education programs. Sales to physicians and distributors have been increasing since the third quarter of 2003.

 

Copper peptide compound shipments are driven by the purchasing patterns of our largest licensee, Neutrogena, which can vary based upon production cycles, adjustments in safety stock and other factors beyond our control.  Neutrogena ordered more copper peptide compound in the second quarter of 2004 to support a new product expected to be launched later in 2004.  Management expects demand from Neutrogena for copper peptide compound, on an annualized basis, to be the same as or slightly higher than the 2003 full year.  Therefore, the increase in the second quarter of 2004 as compared to the comparable 2003 quarter is not indicative of the results to be expected in subsequent periods.

 

Royalty revenue is based upon sales generated by our licensees.  Royalty revenues may fluctuate from quarter to quarter, due to the licensees’ timing of new market launches, special promotions and other factors beyond the Company’s control.  Royalties received from Neutrogena in the second quarter of 2004 were 28 percent lower than the comparable 2003 quarter primarily due to differences in the timing of our licensees’ promotions and expansions into new territories.  New territory introductions, such as those which occurred in the 2003 quarter, require initial shipments that are larger than normal to support the product introductions and fill the pipeline, which can cause variations in quarterly comparisons.  Upon the expiration of the underlying patent in February 2005, the agreement specifies that lower royalty percentages be used for the remaining term, the impact of which is a reduction in the average effective royalty rate of approximately 32 percent. The actual dollar amount of royalty income recognized in future periods is dependent upon both the royalty percentages in effect during the period and the actual applicable sales reported by Neutrogena, which can vary from quarter to quarter.  Therefore, the historical growth in royalty revenue may not be an indication of future results.

 

Gross Profit

 

Gross profit for the 2004 second quarter increased by $514,000, or 26 percent, over the second quarter of 2003 to $2.5 million.  Gross margin for the 2004 quarter was 69 percent as compared to 77 percent in the

 

15



 

2003 quarter.  The increase in gross profit is primarily from the 35% increase in product revenues for the second quarter, which was partially offset by the decrease in royalty revenue for the 2004 quarter.  The decrease in gross margin percentage is primarily due to the lower margin copper peptide compound sales representing 20% of revenue in the 2004 second quarter as compared to 11% of revenue in the 2003 second quarter.  Gross margin is sensitive to the revenue mix of packaged products, copper peptide compound and royalty revenue and will vary from period to period as a result.

 

Operating Expenses

 

 

 

(in thousands)

 

 

 

 

 

Three Months Ended June 30,

 

 

 

 

 

2004

 

2003

 

% Change

 

Marketing and selling

 

$

1,260

 

$

814

 

55

%

Research, general and administrative

 

1,057

 

967

 

9

%

Loss on asset impairment

 

294

 

 

 

Total operating expenses

 

$

2,611

 

$

1,781

 

47

%

 

Marketing and selling expenses for the second quarter of 2004 increased primarily due to increased salary, benefit and travel costs from additional headcount in the 2004 second quarter, higher commission expense related to the 35% increase in current quarter product sales and $226,000 of expenses related to the spa distribution business in the 2004 quarter.  This is partially offset by $79,000 in costs related to the development and testing of an infomercial included in the second quarter of 2003 and not repeated in 2004.

 

Research, general and administrative expenses for the 2004 second quarter increased 9 percent over the comparable 2003 period.  This was primarily due to Emerald not making rental and other payments of approximately $120,000 under its sublease and other agreements with ProCyte because of Emerald’s cessation of business operations in February 2004.  Such payments offset the Company’s rent expense in the 2003 period.  In addition, when comparing the 2004 second quarter to the comparable 2003 period, compensation and employee benefit expenses increased due to the addition of personnel and general market increases, legal expenses increased due to the timing of patent related work, operating costs increased due to higher shipping volume, and the addition of spa operations in the 2004 second quarter period.  These increased expenses were partially offset by a $207,000 decrease in bad debt expense due to the receipt of payments in 2004 from accounts previously written off in prior periods and a lower accrual for estimated bonuses in the 2004 second quarter as compared to the comparable 2003 period.

 

Loss on asset impairment relates to the portion of our facility formerly sub-leased to Emerald.  The Company currently is in negotiations to sell substantially all the assets related to its former manufacturing operation (which it accepted from Emerald under the foreclosure process described above).  The sale is contingent upon entering into a binding definitive asset purchase agreement with the buyer and the successful negotiation of new leases with the landlord, under terms acceptable to both ProCyte and the prospective buyer.  Based upon the information known at this time, including management’s assessment of the probability of completing the sale and considering the estimated fair value of the assets received, ProCyte has taken an impairment charge of $294,000 at June 30, 2004.

 

Interest and Other Income

 

Interest and other income earned during the second quarter of 2004 increased primarily due to interest income of $34,000 recognized on the final settlement of accounts receivable from a former licensee and

 

16



 

written off in 2002.  This increase was partially offset by a decrease in interest not received on the Emerald note.

 

Net Loss

 

For the second quarter ended June 30, 2004, ProCyte reported a net loss of $29,000 as compared to net income of $269,000 for the comparable 2003 period.  This decrease was primarily due to the $294,000 asset impairment charge recognized in June 2004.  The effect of this impairment was partially offset by a gross profit that increased at a greater rate than operating expenses, excluding the impairment.

 

Six Months Ended June 30, 2004 and 2003

 

Revenue

 

 

 

(in thousands)

 

 

 

 

 

Six Months Ended June 30,

 

 

 

 

 

2004

 

2003

 

% Change

 

Products

 

$

5,151

 

$

3,980

 

29

%

Copper peptide compound

 

1,164

 

1,215

 

(4

)%

Royalties

 

589

 

783

 

(25

)%

 

 

$

6,904

 

$

5,978

 

16

%

 

Product revenues for the first half of 2004 increased $1.2 million, or 29 percent, over the first half of 2003.  The increase was primarily due to a 28 percent increase in sales to physicians and the additional sales related to the spa distribution business included in the 2004 period.  Product revenues in the first half of 2003 had been impacted by the slowdown in patient traffic experienced by our dermatology, plastic and cosmetic surgery customers at the beginning of the 2003 year.  Product revenues began recovering during the second half of 2003, in part reflecting certain actions taken such as changing our hiring profile for sales representatives, increasing sales training and expanding customer education programs.

 

Copper peptide compound shipments are driven by the purchasing patterns of our largest licensee, Neutrogena, which can vary based upon production cycles, adjustments in safety stock and other factors beyond our control.  As a result of the additional orders of copper peptide compound from Neutrogena in the second quarter of 2004, the amount of copper peptide compound delivered to Neutrogena during the first half of 2004 is comparable to the amount delivered in the first half of 2003.

 

Royalty revenue is based upon sales generated by our licensees.  Royalty revenues may fluctuate from quarter to quarter, due to the licensees’ timing of new market launches, special promotions and other factors beyond the Company’s control.  Royalties received from Neutrogena in the first half of 2004 were 25 percent lower than the corresponding 2003 period principally due to a large one-time customer shipment by Neutrogena, mostly in the 2003 first quarter.

 

Gross Profit

 

Gross profit for the first half of 2004 increased by $710,000, or 17 percent, to $4.9 million.  Gross margin for the first half of 2004 was 71 percent as compared to 70 percent in the corresponding 2003 period.  The increase in gross profit during the first half of 2004 is primarily due to the 29% increase in product sales which was partially offset by the decrease in royalty revenue when compared to the first

 

17



 

half of 2003. The increase in gross margin percentage is due to a slightly different revenue mix in the two periods being compared.

 

Operating Expenses

 

 

 

(in thousands)

 

 

 

 

 

Six Months Ended June 30,

 

 

 

 

 

2004

 

2003

 

% Change

 

Marketing and selling

 

$

2,458

 

$

2,213

 

11

%

Research, general and administrative

 

2,148

 

1,934

 

11

%

Loss on asset impairment

 

294

 

 

 

Total operating expenses

 

$

4,900

 

$

4,147

 

18

%

 

Marketing and selling expenses for the first half of 2004 increased primarily due to increased activity during the period.  Of the increase, approximately $550,000 was related to higher salary, benefit and travel costs from increased headcount supporting selling efforts in the 2004 period, higher commission expense related to the 29% increase in current period product sales and increased legal expenses related to the establishment and defense of the Company’s trademarks.  In addition, the first half of 2004 includes approximately $367,000 of expenses related to the spa distribution business not included in the 2003 period.  These increases are partially offset by $687,000 in costs related to the development and testing of an infomercial included in the 2003 period and not repeated in 2004.

 

Research, general and administrative expenses for the first half of 2004 increased 11 percent over the comparable 2003 period.  This was primarily due to Emerald not making rental and other payments totaling $210,000 under its sublease and other agreements with ProCyte because of Emerald’s cessation of business operations in February 2004.  Such payments offset the Company’s rent expense in the 2003 period.  In addition, when comparing the first half of 2004 to the comparable 2003 period, compensation and employee benefit expenses increased due to the addition of personnel and general market increases, legal expenses increased due to the timing of patent related work, operating costs increased due to higher shipping volume, and the addition of spa operations in the 2004 period.  These increased expenses were mostly offset by a $240,000 decrease in bad debt expense due to the receipt of payments in 2004 from accounts previously written off or included in the allowance for doubtful accounts in prior periods and a lower accrual for estimated bonuses in the first half of 2004 as compared to the comparable 2003 period.

 

Interest and Other Income

 

Interest and other income earned during the first half of 2004 decreased $75,000 to $50,000 primarily due to a decrease of $53,000 in interest income not recognized on the Emerald note in the 2004 period due to Emerald’s suspension of operations in February 2004 and a termination settlement of $50,000 received from Merck KGaA in the first half of 2003.  These decreases were partially offset by interest income of $34,000 recognized on the final settlement of accounts receivable from a former licensee and written off in 2002.

 

Net Income

 

For the six months ended June 30, 2004, ProCyte reported net income of $21,000 as compared to net income of $136,000 for the comparable 2003 period.  This decrease was primarily due to the $294,000 asset impairment charge recognized in June 2004.  The effect of this impairment was partially offset by gross profit that increased at a greater rate than operating expenses, excluding the impairment.

 

18



 

Liquidity and Capital Resources

 

The Company relies primarily on cash flow from operations to fund its operations and capital expenditures.  At June 30, 2004, the Company had approximately $5.7 million in cash and cash equivalents, compared to $3.8 million at December 31, 2003.  The net change in cash and cash equivalents during the first half of 2004 reflects a net increase in cash of $1.9 million.  The significant components of this positive cash increase are from the net reduction of the Company’s copper peptide compound inventory, the reduction in accounts receivable, the receipt of payment on a note due from an officer, an increase in trade payables for inventory received near the end of the period, and the receipt of a customer deposit under a supply contract.  Positive cash generated was partially offset by the reduction in cash flow from Emerald as discussed below, the payment of the 2003 management bonuses in March 2004 and net cash used in support of the recently acquired spa products distribution business (“Spa”). 

 

As of February 2004, Emerald Pharmaceuticals, L.P. suspended operations and in fiscal 2003 ProCyte recorded an impairment related to its $2.0 million note receivable due to the uncertainty that the full amount would be collected.  Emerald also leased its facility from ProCyte under an operating sublease.  During the first half of 2004, except for January rent, ProCyte did not receive the interest and rental payments due under its agreements with Emerald.  Therefore, cash flow from operations has been reduced by $40,000 per month, from the comparable 2003 period.  ProCyte terminated the sublease on June 25, 2004 in order to take back the facility and protect the Company’s collateral and other interests.  Effective that date, ProCyte become responsible for facility related operating expenses such as utilities, insurance and security estimated to be an additional $11,000 per month.  In addition, ProCyte will be responsible for facility shut down costs estimated to be $35,000 to $50,000.

 

Due to inventory limitations and the need to change certain packaging, Spa sales have developed slower than originally planned at the time of the acquisition and as such Spa sales activity has not provided positive cash from operations as of June 30, 2004.  Based upon recent experience and current plans, ProCyte believes that additional cash of up to $200,000 could be required over the next two quarters.

 

We may see fluctuations in operating cash flows in future periods as they depend in large part on the timing of deposits received from our licensees and their initiation of new product introductions and the timing of shipments to and payments received from our customers.  In addition to these factors, the second half of 2004 will have cash inflows of $167,000 from the cash payment the Company received in July 2004 as full settlement of a judgment ProCyte obtained against a former licensee. ProCyte is also in negotiations to sell substantially all the assets related to its former manufacturing operation to a third party.  The sale is contingent upon entering into a binding definitive asset purchase agreement with the proposed buyer and the successful negotiation of new leases with the landlord under terms acceptable to both ProCyte and the proposed buyer.  Based upon the information known at this time, including management’s assessment of the probability of completing the sale and considering the estimated fair value of the assets received, ProCyte took an impairment charge of $294,000.

 

The Company believes that its existing cash and cash equivalents and interest thereon, will be sufficient to meet its working capital requirements for at least the next two years.  However, there can be no assurance that the underlying forecasts of revenue and expense will prove to have been accurate.  The Company’s actual cash requirements will depend upon numerous factors, including the levels of resources that the Company devotes to taking advantage of strategic acquisitions and/or establishing and maintaining marketing, sales and distribution capabilities, the emergence of competitive products and other adverse market developments, the timing and amount of revenues and expense reimbursements resulting from relationships with third parties, the Company’s degree of success in commercializing new

 

19



 

products and the cost of preparing, filing, prosecuting, maintaining and enforcing patent claims and intellectual property rights, and actions by regulatory authorities.  The Company will depend on product revenues, royalties and license fees, interest income, equity financing, and funding from corporate alliances to meet its future capital needs.  See “Additional Information About the Company’s Business; Risk Factors.”

 

Additional Information About the Company’s Business; Risk Factors

 

Loss of or Reduction in Orders by Significant Customers Could Adversely Affect Our Net Revenues and Results of Operations

 

Although the Company’s customer base is made up of a large number of customers, Neutrogena accounted for approximately 25 percent of the Company’s net revenue during the first half of 2004 and our top 10 customers comprised approximately 32 percent of such net revenues.  Any decrease in or loss of revenues from these customers could have an adverse effect on our net revenues and results of operations or impair our ability to increase net revenues.  The Neutrogena technology license agreement expires in April 2010, however the royalty payments related to each territory continue for a period not less than five-years from the date products were first sold in each territory, which may extend the royalty period beyond 2010 for certain territories.  Royalty revenue from the Neutrogena license agreement accounted for 8 percent and 13 percent of the Company’s net revenues in the first half of 2004 and 2003, respectively.  The patent related to the Neutrogena license agreement expires February 5, 2005, the effect of which will be a reduction in the percentage paid as royalty during the remaining royalty period as set forth in the agreement.  Revenues from sale of copper peptide compound to Neutrogena pursuant to a related supply agreement, accounted for 17 percent and 20 percent of net revenues in the first half of 2004 and 2003, respectively. The supply agreement expires in April 2005, with extensions for additional two-year terms by mutual consent of the parties up to April 2010.  There can be no assurance that this agreement will be extended beyond April 2005, or if extended, that it will be extended to April 2010.  Also, the timing of copper peptide compound shipments are driven by Neutrogena’s purchasing patterns, which can vary based upon production cycles, adjustments in safety stock and other factors beyond our control, causing the revenue from copper peptide compound sales to fluctuate from quarter to quarter.

 

We expect that we will continue to depend on revenue from larger customers, generally under multi-year license or supply agreements.  Such agreements can be terminated under certain circumstances, including our inability to supply product within required time frames.  Any downturn in the business from these customers or the inability to renew or replace agreements with new customers as they expire could significantly decrease sales to such customers, which could adversely affect our net revenues and results of operations.

 

Furthermore, we ship most orders when received.  Virtually all orders are shipped within 48 hours and therefore we do not have a substantial non-cancelable backlog of orders.  Variations in the timing of orders can cause significant fluctuations in our quarterly operating results, and the cancellation or deferral of product orders or overproduction due to the failure of anticipated orders to materialize could result in us holding excess or obsolete inventory, which has resulted and could again in the future result in write-downs of inventory that would have a material adverse effect on our operating results.

 

Dependence on and Management of Existing and Future Corporate Alliances

 

The successful commercialization of the Company’s existing and future products in the mass retail, prestige, specialty retail, and home shopping categories and wound care markets will depend upon ProCyte’s ability to enter into and effectively manage corporate alliances.  There can be no assurance

 

20



 

that the Company will be successful in establishing corporate alliances in the future, or that it will be successful in performing and maintaining existing or any future corporate alliances.  Moreover, there can be no assurance that the interests and motivations of any distributor, licensee or other alliance party would be or remain consistent with those of the Company, or that the Company and such distributors,  licensees or alliance party will successfully perform the necessary technology transfer, clinical development, regulatory compliance, manufacturing, marketing, commercialization and other obligations under their agreements. Any of these failures could have a material adverse effect on the Company’s business, financial condition and results of operations.

 

Recent Profitability; Profitability May Fluctuate in Future Periods

 

The Company has been marketing products based on its proprietary copper peptide technology since 1996.  In addition to sales of products based on its proprietary copper peptide technology, the Company’s revenues have historically included sales of non-proprietary products, license fees and royalties, revenue from contract manufacturing and interest income.  The contract manufacturing operation was sold in July 2001.  During fiscal 2002, the Company reported net profits and positive cash flow from operations for the first time in its operating history.  During 2003, the Company reported net income before tax benefit and break even cash flow from operations.  During the first half of 2004, the company reported a net profit and positive cash flow from operations.  Attaining consistent profitability is dependent upon a wide variety of factors, including successfully manufacturing and marketing of the Company’s products, entering into and maintaining agreements with third parties for commercialization of the Company’s products, successfully licensing the Company’s products and technology and general economic conditions, including those which affect demand for the services of our dermatologist, plastic and cosmetic surgery customers.  Payments under corporate alliances and licensing arrangements may be subject to fluctuations in both timing and amounts and therefore the level of profitability may vary significantly from quarter to quarter.

 

We Rely On Third Party Manufacturers for Our Products

 

We use third party manufacturers to make products. In many cases, third party manufacturers are not obligated under contracts that fix the term of their commitments and they may discontinue production upon little or no advance notice.  Manufacturers also may experience problems with product quality or timeliness of product delivery.  We rely on these manufacturers to comply with applicable current quality system regulations (“QSR”).  The loss of a contract manufacturer may force us to shift production to in-house facilities and possibly cause manufacturing delays, disrupt our ability to fill orders, or require us to suspend production until we find another third party manufacturer.  We are not able to control the manufacturing efforts of these third party manufacturers as closely as we control our business.  Should any of these manufacturers fail to meet the applicable standards, we or our third-party manufacturer could face various enforcement actions, which would have an adverse effect on our net revenues and results of operations.

 

Need for Additional Capital

 

The Company generated positive cash from operations in the first half ended June 30, 2004 and break even cash flow from operations in 2003.  The Company currently expects that it will generate positive cash flow from operations in 2004.  As of June 30, 2004, the Company had cash and cash equivalents of $5.7 million.  The Company estimates that, at its planned rate of spending, its existing cash and cash equivalents and the interest income thereon will be sufficient to meet its operating and capital requirements for at least the next two years.  There can be no assurance, however, that our underlying assumed levels of revenue and expense will prove accurate.  Whether or not these assumptions prove to be accurate, the Company may need to raise additional capital as the Company may require additional

 

21



 

funds to expand or enhance its sales and marketing activities, to accelerate product development, or to acquire a product line or company.  The Company may be required to seek this additional funding through public or private financing, including equity financing, or through collaborative arrangements.  Adequate funds for these purposes, whether obtained through financial markets or from collaborative or other arrangements, may not be available when needed or may not be available on terms favorable to the Company.  If we issue equity securities to raise additional funds, dilution to existing shareholders will result.  If funding is insufficient at any time in the future, the Company may be required to: delay, scale back or eliminate some or all of its marketing and research and development programs; or license to third parties the rights to commercialize products or technologies that the Company would otherwise seek to develop on its own.  Furthermore, the terms of any such license agreements or asset sales might be less favorable than if the Company were negotiating from a stronger position.

 

Uncertainty of Patent Position and Proprietary Rights

 

The patent positions of biotechnology, medical device and healthcare products companies are often uncertain and involve complex legal and factual questions, and the breadth of claims allowed in such patents cannot be predicted.  The Company’s success will depend on its ability to obtain patents and licenses to patent rights, to maintain trade secrets, and to operate without infringing on the proprietary rights of others, both in the United States and in other countries.  The failure of the Company or its licensors to obtain, maintain and enforce patent protection for the Company’s technology could have a material adverse effect on the Company.

 

ProCyte’s success depends, in part, upon its ability to protect its products, technology and trademarks under intellectual property laws in the United States and abroad.  The Company receives a significant amount of its revenue from technology licensing agreements, which are dependent upon patents, and expects to continue licensing its technology for certain markets.  Royalty revenue from the Neutrogena license agreement accounted for 8 percent and 13 percent of the Company’s net revenues in the first half of 2004 and 2003, respectively and is based upon Neutrogena’s applicable sales, as set forth in the agreement, multiplied by specified royalty percentages.  The patent related to the Neutrogena license agreement expires February 5, 2005.  Upon expiration of this patent, the agreement specifies that lower royalty percentages be used for the remaining term, the impact of which is a reduction in the average effective royalty rate of approximately 32 percent.  The actual amount of royalty income recognized in future periods is dependent upon the royalty percentages in effect during the period and the actual applicable sales reported by Neutrogena, which can vary from quarter to quarter.    The expiration of the patent would also allow others, including Neutrogena, to manufacture the compound.  The supply agreement expires in April 2005, with extensions for additional two-year terms by mutual consent of the parties up to April 2010.  There can be no assurance that this agreement will be extended beyond April 2005, or if extended, that it will be extended to April 2010.

 

As of July 31, 2004, the Company had 19 issued US patents expiring between 2005 and 2017 and numerous issued foreign patents and patent registrations.  In addition, the Company has 12 patents applied for of which 6 have been published and are pending action by the United States Patent & Trademark Office.  The patents relate to use of the Company’s copper peptide-based technology for a variety of healthcare applications, and to the composition of certain biologically active, synthesized compounds.  The Company’s strategy has been to apply for patent protection for certain compounds and their discovered uses that are believed to have potential commercial value in countries that offer significant market potential.  There can be no assurance that patent applications relating to the technology used by the Company will result in patents being issued.  Nor can there be any assurance that any patent issued to the Company will not be subject to further proceedings limiting the scope of the rights under the patent or that such patent will provide a competitive advantage, will afford protection

 

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against competitors with similar technology, or will not be successfully challenged, invalidated or circumvented by competitors.

 

The Company’s processes and potential products may conflict with patents that have been or may be granted to competitors and others.  As the biotechnology, medical device and healthcare industries expand and more patents are issued, the risk increases that the Company’s processes and potential products may give rise to claims that they infringe the patents of others.  Such other persons could bring legal actions against the Company claiming damages and seeking to enjoin clinical testing, manufacturing and marketing of the affected product or use of the affected process.  Litigation may be necessary to enforce patents issued to the Company, to protect trade secrets or know-how owned by the Company or to determine the enforceability, scope and validity of proprietary rights of others.  If the Company becomes involved in such litigation, it could result in substantial expense to the Company and significant diversion of effort by the Company’s technical and management personnel.  In addition to any potential liability for significant damages, the Company could be required to obtain a license to continue to manufacture or market the affected product or use the affected process.  Costs associated with any licensing arrangement may be substantial and could include ongoing royalties.  There can be no assurance that any license required under any such patent would be made available to the Company on acceptable terms, if at all.  If such licenses could not be obtained on acceptable terms, the Company could be prevented from manufacturing and marketing existing or potential products.  Accordingly, an adverse determination in such litigation could have a material adverse effect on the Company’s business, financial condition and results of operations.  The Company is not aware of any conflicts at this time.

 

The Company also relies upon non-patented proprietary technology.  There can be no assurance that the Company can meaningfully protect its rights to such non-patented technology, that any obligation to maintain the confidentiality of such proprietary technology will not be breached by employees, consultants, collaborators or others or that others will not independently develop or acquire substantially equivalent technology.  To the extent that licensees or consultants apply Company technological information independently developed by them or by others to Company projects or apply Company technology or know-how to other projects, disputes may arise as to the ownership of proprietary rights to such information.  Any failure to protect non-patented proprietary technology or any breach of obligations designed to protect such technology or development of equivalent technology may have a material adverse effect on the Company’s business, financial condition and results of operations.

 

Uncertainty of Government Regulatory Requirements

 

The Federal Food, Drug and Cosmetic Act, and the regulations promulgated thereunder, and other federal and state statutes govern, among other things, the testing, manufacture, safety, labeling, storage, record-keeping, advertising and promotion of cosmetic products and medical devices.  The Company’s products and product candidates may be regulated by any of a number of divisions of the FDA and in other countries by similar health and regulatory authorities.  The process of obtaining and maintaining regulatory approvals for the manufacturing or marketing of the Company’s existing and potential products is costly and time-consuming and is subject to unanticipated delays.  Regulatory requirements ultimately imposed could also adversely affect the ability of the Company to clinically test, manufacture or market products.

 

In the United States, products that do not seek to make effectiveness claims based on human clinical evaluation may be subject to review and regulation under the FDA’s cosmetic, drug or 510(k) medical device guidelines.  Similar guidelines exist for such products in other countries.  Such 510(k) products, which include wound care dressings and certain ointments and gels, must show safety and substantial equivalency with predicate products already cleared by the FDA to be marketed.  There can be no

 

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assurance that product applications submitted to the FDA or similar agencies in other countries will receive clearance to be marketed, or that the labeling claims sought will be approved, or that, if cleared, such products will be commercially successful or free from third party claims relating to the effectiveness or safety of such products.

 

The Company also is or may become subject to various other federal, state, local and foreign laws, regulations and policies relating to, among other things, safe working conditions, good laboratory practices, and the use and disposal of hazardous or potentially hazardous substances used in connection with research and development.

 

Failure to obtain regulatory approvals where appropriate for its product candidates or to attain or maintain compliance with QSR or other manufacturing requirements would have a material adverse effect on the Company’s business, financial condition and results of operations.

 

Intense Competition

 

Competition in the wound care, skin health and hair care markets is intense.  The Company’s competitors include well-established pharmaceutical, cosmetic and healthcare companies such as Obagi, La Roche Posay, Allergan, Pevonia, Declore and Murad.  These competitors have substantially more financial and other resources, larger research and development staffs, and more experience and capabilities in researching, developing and testing products in clinical trials, in obtaining FDA and other regulatory approvals and in manufacturing, marketing and distribution than the Company.  In addition, a number of smaller companies are developing or marketing competitive products.  The Company’s competitors may succeed in developing and commercializing products or obtaining patent protection or other regulatory approvals for products more rapidly than the Company.  In addition, competitive products may be manufactured and marketed more successfully than the Company’s potential products.  Such developments could render the Company’s existing or potential products less competitive or obsolete and could have a material adverse effect on the Company’s business, financial condition and results of operations.

 

Product Liability Claims

 

The testing, manufacturing, marketing and sale of our products may subject the Company to product liability claims.  ProCyte maintains insurance coverage against product liability risks up to an aggregate annual limit of $10 million.  However, continuing insurance coverage may not be available at an acceptable cost, if at all.  The Company may not be able to obtain insurance coverage that will be adequate to satisfy any liability that may arise.  Regardless of merit or eventual outcome, product liability claims may result in decreased demand for a product, injury to its reputation, withdrawal of clinical trial volunteers and loss of revenues.  As a result, regardless of whether the Company is insured, a product liability claim or product recall may result in losses that could be material to ProCyte.

 

Potential Volatility of Stock Price; Bulletin Board Listing

 

The market prices for securities of healthcare, pharmaceutical and biotechnology companies are subject to volatility, and the market has from time to time experienced significant fluctuations that are unrelated to the operations of the Company.  ProCyte’s market price has fluctuated over a wide range since the Company’s initial public offering in 1989, and since March 25, 1999, the Company’s common stock has traded on the NASD OTC bulletin board.  Because real-time price information may not be easily available for bulletin board securities, an investor is likely to find it more difficult to dispose of, or to obtain accurate quotations on the market value of, the Company’s securities than if they were listed on a the Nasdaq or a national exchange.  In addition, purchases and sales of the Company’s securities may

 

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become subject to Rule 15g-9 of the Securities Exchange Act of 1934, which imposes various sales practice requirements on broker-dealers, or to the “penny stock” rules, either of which would likely reduce the level of trading activity in the secondary market for the Company’s securities and make selling the securities more difficult for an investor.

 

Announcements concerning the Company or its competitors, including fluctuations in operating results, research and development program direction, results of clinical trials, addition or termination of corporate alliances, technology licenses, clearance or approval to market products, announcements of technological innovations or new products by the Company or its competitors, changes in government regulations, healthcare reform, developments in patent or other proprietary rights of the Company or its competitors, litigation concerning business operations or intellectual property, or public concern as to safety of products, as well as changes in general market conditions and mergers and acquisitions, may have a significant effect on the market price of ProCyte’s common stock.

 

Item 3.  Quantitative and Qualitative Disclosures About Market Risk

 

For a discussion of our market risks, refer to the Item 7A, “Quantitative and Qualitative Disclosures About Market Risk,” in our Annual Report on Form 10-K for the year ended December 31, 2003. There have been no material changes to the information provided that would require additional information with respect to the six months ended June 30, 2004.

 

Item 4.  Controls and Procedures

 

As of the end of the period covered by this report, the Company conducted an evaluation, under the supervision and with the participation of its principal executive officer and principal financial officer, of the effectiveness and design of its disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934 (the “Exchange Act”)).  Based on this evaluation, the principal executive officer and principal financial officer concluded that these disclosure controls and procedures were effective as of June 30, 2004, in ensuring that the information required to be disclosed by the Company in reports it files or submits under the Exchange Act within the time periods specified in the SEC rules and forms.

 

There were no changes in the Company’s internal controls over financial reporting during the second quarter of 2004 that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.

 

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Part II - Other Information

 

Item 4.  Submission of Matters to a Vote of Security Holders

 

The annual meeting of the shareholders of the Company was held on May 19, 2004.  Three matters were submitted to the shareholders for a vote:  election of directors, the approval of the ProCyte Corporation 2004 Stock Option Plan, and ratifying the appointment of Deloitte & Touche LLP as independent auditors of the Company for the year ending December 31, 2004.  As of April 2, 2004, the record date, there were 15,798,747 shares eligible to vote at the meeting, of which, 93.8% or 14,821,136 were represented at the meeting, constituting a quorum.

 

The four nominees for election as directors were elected to serve until the 2005 annual meeting of the shareholders, and until the election and qualification of their respective successors.  The vote for each director follows:

 

Directors

 

For

 

Withheld

 

John F. Clifford

 

14,155,349

 

665,787

 

Matt L. Leavitt

 

14,164,083

 

657,053

 

Robert E. Patterson

 

14,188,443

 

632,693

 

John M. Hammer

 

13,826,533

 

994,603

 

 

The second proposal was approved by the shareholders.  The vote was as follows:

 

Proposal

 

For

 

Against

 

Abstain

 

Approve the ProCyte Corporation 2004 Stock Option Plan

 

3,559,459

 

1,189,575

 

155,015

 

 

The third proposal was approved by the shareholders.  The vote was as follows:

 

Proposal

 

For

 

Against

 

Abstain

 

Ratify the appointment of Deloitte & Touche LLP as independent auditors of the Company for the year ended December 31, 2004

 

14,573,645

 

177,469

 

70,022

 

 

Item 6.  Exhibits and Reports on Form 8-K

 

(a) Exhibits

 

See Exhibit Index below.

 

(b) Reports on Form 8-K

 

Form 8-K filed May 5, 2004 announcing the Company’s earnings for the first quarter ended March 31, 2004.

 

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Signatures

 

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

 

 

ProCyte Corporation

 

 

 

 

Date:  August 12, 2004

By:

/s/ John F. Clifford

 

 

 

 

 

John F. Clifford, Chairman and CEO

 

 

 

Date:  August 12, 2004

By:

/s/ Robert W. Benson

 

 

 

 

 

Robert W. Benson, Chief Financial Officer

 

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Exhibit Index

 

Exhibit

 

Description

 

Note

3.1

 

Restated Articles of Incorporation of the Registrant

 

A

3.2

 

Restated Bylaws of the Registrant

 

A

4.1

 

Rights Agreement between the Registrant and American Securities Transfer and Trust as of December 7, 1994

 

G

10.1*

 

1987 Stock Benefit Plan of ProCyte Corporation

 

A

10.2*

 

ProCyte Corporation 1989 Restated Stock Option Plan

 

B

10.3*

 

ProCyte Corporation 1991 Restated Stock Option Plan for Non-employee Directors and amendments thereto

 

D

10.4†

 

Teachers Insurance & Annuity Association Lease dated as of October 1, 1993 and second amendment thereto dated February 28, 1997

 

D

10.5*

 

1996 Stock Option Plan

 

D

10.6*

 

ProCyte Corporation 1998 Non-employee Director Stock Plan

 

F

10.7*

 

Change of Control Agreement for Ms. Robin Carmichael

 

K

10.8*

 

Change of Control Agreement for Mr. John Clifford

 

K

10.9*

 

Change of Control Agreement for Mr. Robert Benson

 

K

10.13*

 

Form of Indemnity Agreement dated February 23, 1995 between the Registrant and each of Dr. Blake, Mr. Patterson and Mr. Clifford.

 

C

10.14*

 

Form of Indemnity Agreement between ProCyte Corporation and each of various of its Officers and Directors

 

F

10.15*

 

Severance Agreement for Mr. John Clifford

 

K

10.16*

 

Form of Promissory Note between ProCyte Corporation and Mr. John Clifford

 

H

10.17†

 

License Agreement dated April 19, 2000 between ProCyte Corporation and Neutrogena Corporation

 

I

10.18*

 

ProCyte Corporation 2004 Stock Option Plan

 

K

31.1

 

Rule 13a-14(a)/15d-14(a) Certification of Chief Executive Officer

 

K

31.2

 

Rule 13a-14(a)/15d-14(a) Certification of Chief Financial Officer

 

K

32.1

 

Section 1350 Certification of Chief Executive Officer

 

K

32.2

 

Section 1350 Certification of Chief Financial Officer

 

K

 


*                 Management contract or compensatory plan or arrangement.

                  Confidential treatment has been granted or requested with respect to portions of this exhibit.

A              Incorporated by reference to the Registrant’s Registration Statement of Form S-1 (No. 33-31353).

B                Incorporated by reference to the Registrant’s Registration Statement of Form S-1 (No. 33-46364).

C                Incorporated by reference to the Registrant’s Annual Report on Form 10-K for the year ended December 31, 1994.

D               Incorporated by reference to the Registrant’s Annual Report on Form 10-K for the year ended December 31, 1996.

F                 Incorporated by reference to the Registrant’s Quarterly Report on Form 10-Q for the Quarter ended June 30, 1998.

G                Incorporated by reference to the Registrant’s Amended Annual Report on Form 10-K/A dated December 31, 1997.

H               Incorporated by reference to the Registrant’s Amended Annual Report on Form 10-K/A dated December 31, 1998.

I                    Incorporated by reference to the Registrant’s Quarterly Report on Form 10-Q for the Quarter ended March 31, 2000.

J                   Incorporated by reference to the Registrant’s Annual Report on Form 10-K for the year ended December 31, 2003.

K               Filed herewith.

 

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