CollaGenex Pharmaceuticals (CGPI)

 
Annual Reports

 
Quarterly Reports

  • 10-Q (Jan 19, 2010)
  • 10-Q (Jul 6, 2009)
  • 10-Q (Apr 20, 2009)
  • 10-Q (Nov 7, 2007)
  • 10-Q (Aug 9, 2007)
  • 10-Q (May 3, 2007)

 
8-K

 
Other

CollaGenex Pharmaceuticals 10-Q 2007

Documents found in this filing:

  1. 10-Q
  2. Ex-31.1
  3. Ex-31.2
  4. Ex-32.1
  5. Ex-32.1

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

 


 

FORM 10-Q

 

(MARK ONE)

 

x

 

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

 

 

 

For the quarterly period ended September 30, 2007

 

 

 

o

 

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

 

For the transition period from     to    

 

Commission File Number 0-28308

 

CollaGenex Pharmaceuticals, Inc.

(Exact Name of Registrant as Specified in Its Charter)

 

Delaware

 

52-1758016

(State or Other Jurisdiction of
Incorporation or Organization)

 

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

 

 

 

41 University Drive, Newtown, PA

 

18940

(Address of Principal Executive Offices)

 

(Zip Code)

 

(215) 579-7388

(Registrant’s Telephone Number, Including Area Code)

 

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: x

 

No: o

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer or a non-accelerated filer. See definition of “accelerated filer and large accelerated filer” in Rule 12b-2 of the Exchange Act. (Check one):

 

Large accelerated filer o

 

Accelerated filer x

 

Non-accelerated filer o

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).

 

Yes: o

 

No: x

 

Indicate the number of shares outstanding of each of the issuer’s classes of common stock as of November 1, 2007:

 

Class

 

Number of Shares

Common Stock $.01 par value

 

21,473,546

 

 



 

COLLAGENEX PHARMACEUTICALS, INC.

 

TABLE OF CONTENTS

 

PART I.   FINANCIAL INFORMATION

 

 

 

 

 

 

Item 1.

Financial Statements (unaudited)

 

 

 

 

 

 

 

Condensed Consolidated Balance Sheets as of September 30, 2007 (unaudited) and December 31, 2006

 

 

 

 

 

 

 

Condensed Consolidated Statements of Operations for the Three Months Ended September 30, 2007 and 2006 (unaudited)

 

 

 

 

 

 

 

Condensed Consolidated Statements of Operations for the Nine Months Ended September 30, 2007 and 2006 (unaudited)

 

 

 

 

 

 

 

Condensed Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2007 and 2006 (unaudited)

 

 

 

 

 

 

 

Notes to Condensed Consolidated Financial Statements (unaudited)

 

 

 

 

 

 

Item 2.

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

 

 

 

 

 

 

 

Results of Operations

 

 

 

 

 

 

 

Liquidity and Capital Resources

 

 

 

 

 

 

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

 

 

 

 

 

 

Item 4.

Controls and Procedures

 

 

 

 

 

 

PART II. OTHER INFORMATION

 

 

 

 

 

 

Item 1A.

Risk Factors

 

 

 

 

 

 

Item 5.

Other Information

 

 

 

 

 

 

Item 6.

Exhibits

 

 

 

 

 

 

SIGNATURES

 

 

 

CollaGenex Pharmaceuticals, Inc. trademarks:

 

Oracea®, Periostat®, Metastat®, Dermostat®, Nephrostat®, Osteostat®, Arthrostat®, Rheumastat®, Corneostat®, Gingistat®, IMPACS™, PS20®, The Whole Mouth Treatment®, Restoraderm®, Dentaplex®, Lytra®, Periostat-MR™, SansRosa®, Unorthodoxy™, Unorthodoxycycline™, Aprecin®, Zedara™, Optistat®, Xerostat®, Periocycline®, Periostatus®, CollaGenex®, Dermastat®, Periostan®, Periostat-SR®, “C” Logo® and “The Whole Mouth Treatment” Logo®, Esteemax™, Rubazil™, Lytrazine™, Palytra™, Lytrazac™, Presteme™, Erubatin™, Rosoral™, Reveeril™, Cycavin™, Zyclinil™, and Impaken™.

 

Marks listed as registered herein may be registered in the United States or in other jurisdictions. All other trade names, trademarks or service marks appearing in this Quarterly Report on Form 10-Q are the property of their respective owners and are not property of CollaGenex Pharmaceuticals, Inc. or any of our subsidiaries.

 

2



 

COLLAGENEX PHARMACEUTICALS, INC.

AND SUBSIDIARIES

Condensed Consolidated Balance Sheets

September 30, 2007 and December 31, 2006

(dollars in thousands, except share data)

(unaudited)

 

 

 

September 30,

 

December 31,

 

 

 

2007

 

2006

 

Assets

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

31,344

 

$

46,493

 

Short-term investments

 

25,552

 

19,337

 

Accounts receivable, net of allowances of $306 and $187 at September 30, 2007 and December 31, 2006, respectively

 

10,768

 

6,071

 

Inventories

 

2,006

 

1,959

 

Prepaid expenses and other current assets

 

2,949

 

2,416

 

Total current assets

 

72,619

 

76,276

 

Equipment and leasehold improvements, net

 

1,350

 

1,008

 

Intangible assets, net

 

1,582

 

1,882

 

Other assets

 

43

 

41

 

Total assets

 

$

75,594

 

$

79,207

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

 

$

5,590

 

$

9,066

 

Accrued expenses

 

8,541

 

7,574

 

Total current liabilities

 

14,131

 

16,640

 

Deferred licensing revenue

 

5,300

 

 

Other non-current liabilities

 

182

 

265

 

Total liabilities

 

19,613

 

16,905

 

Commitments and contingencies (Notes 6 and 11)

 

 

 

 

 

Stockholders’ equity (deficit):

 

 

 

 

 

Preferred stock, $0.01 par value, 5,000,000 shares authorized, 200,000 shares of Series D-1 Cumulative Convertible Preferred Stock issued and outstanding at September 30, 2007 and December 31, 2006 (liquidation value of $20,000 at September 30, 2007 and $21,000 at December 31, 2006);

 

2

 

2

 

 

 

 

 

 

 

150,000 shares of Series A Participating Preferred Stock, designated and no shares issued and outstanding at September 30, 2007 and December 31, 2006

 

 

 

 

 

 

 

 

 

Common stock, $0.01 par value; 75,000,000 shares authorized and 21,472,646 and 21,191,724 shares issued and outstanding at September 30, 2007 and December 31, 2006, respectively

 

215

 

212

 

Additional paid-in capital

 

190,128

 

185,581

 

Accumulated other comprehensive income

 

2

 

7

 

Accumulated deficit

 

(134,366

)

(123,500

)

Total stockholders’ equity

 

55,981

 

62,302

 

Total liabilities and stockholders’ equity

 

$

75,594

 

$

79,207

 

 

See accompanying notes to unaudited condensed consolidated financial statements.

 

3



 

COLLAGENEX PHARMACEUTICALS, INC.

AND SUBSIDIARIES

Condensed Consolidated Statements of Operations

For the Three Months Ended September 30, 2007 and 2006

(amounts in thousands, except share and per share data)

(unaudited)

 

 

 

Three Months Ended September 30,

 

 

 

2007

 

2006

 

Revenues:

 

 

 

 

 

Net product sales

 

$

15,559

 

$

4,991

 

Contract revenues

 

267

 

419

 

License revenues

 

47

 

12

 

Grant revenues

 

60

 

211

 

Total revenues

 

15,933

 

5,633

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

Cost of product sales

 

2,363

 

1,326

 

Research and development

 

4,475

 

3,991

 

Selling, general and administrative

 

10,913

 

10,594

 

Total operating expenses

 

17,751

 

15,911

 

Operating loss

 

(1,818

)

(10,278

)

Other income (expense):

 

 

 

 

 

Interest income

 

772

 

409

 

Interest expense

 

(8

)

(6

)

Net loss

 

(1,054

)

(9,875

)

Preferred stock dividend

 

550

 

500

 

 

 

 

 

 

 

Net loss allocable to common stockholders

 

$

(1,604

)

$

(10,375

)

Net loss per basic and diluted share allocable to common stockholders

 

$

(0.07

)

$

(0.59

)

Weighted average shares used in computing net loss per basic and diluted share allocable to common stockholders

 

21,444,702

 

17,541,225

 

 

See accompanying notes to unaudited condensed consolidated financial statements.

 

4



 

COLLAGENEX PHARMACEUTICALS, INC.

AND SUBSIDIARIES

Condensed Consolidated Statements of Operations

For the Nine Months Ended September 30, 2007 and 2006

(amounts in thousands, except share and per share data)

(unaudited)

 

 

 

Nine Months Ended September 30,

 

 

 

2007

 

2006

 

Revenues:

 

 

 

 

 

Net product sales

 

$

45,534

 

$

11,686

 

Contract revenues

 

734

 

1,040

 

License revenues

 

92

 

44

 

Grant revenues

 

211

 

377

 

Total revenues

 

46,571

 

13,147

 

Operating expenses:

 

 

 

 

 

Cost of product sales

 

6,855

 

3,311

 

Research and development

 

16,164

 

10,587

 

Selling, general and administrative

 

35,703

 

29,291

 

Total operating expenses

 

58,722

 

43,189

 

Operating loss

 

(12,151

)

(30,042

)

Other income (expense):

 

 

 

 

 

Interest income

 

2,393

 

1,444

 

Interest expense

 

(24

)

(6

)

Net loss

 

(9,782

)

(28,604

)

Preferred stock dividend

 

1,578

 

1,428

 

 

 

 

 

 

 

Net loss allocable to common stockholders

 

$

(11,360

)

$

(30,032

)

Net loss per basic and diluted share allocable to common stockholders

 

$

(0.53

)

$

(1.72

)

Weighted average shares used in computing net loss per basic and diluted share allocable to common stockholders

 

21,340,488

 

17,460,749

 

 

See accompanying notes to unaudited condensed consolidated financial statements.

 

5



 

COLLAGENEX PHARMACEUTICALS, INC.

AND SUBSIDIARIES

Condensed Consolidated Statements of Cash Flows

For the Nine Months Ended September 30, 2007 and 2006

(dollars in thousands)

(unaudited)

 

 

 

Nine Months Ended September 30,

 

 

 

2007

 

2006

 

Cash flows from operating activities:

 

 

 

 

 

Net loss

 

$

(9,782

)

$

(28,604

)

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

 

 

 

 

 

Stock-based compensation

 

2,040

 

2,528

 

Write-down of inventories

 

37

 

250

 

Depreciation and amortization expense

 

752

 

453

 

Accounts receivable provisions

 

119

 

98

 

Charge for in-process research and development

 

2,182

 

300

 

Changes in operating assets and liabilities:

 

 

 

Accounts receivable

 

(4,816

)

(6,382

)

Inventories

 

(84

)

(970

)

Prepaid expenses and other current assets

 

(535

)

(769

)

Accounts payable

 

(3,476

)

672

 

Accrued expenses

 

1,892

 

1,292

 

Other non-current liabilities

 

(51

)

2,679

 

Deferred licensing revenue

 

5,300

 

 

Net cash used in operating activities

 

(6,422

)

(28,453

)

Cash flows from investing activities:

 

 

 

 

 

Capital expenditures

 

(740

)

(386

)

Purchase of in-process research and development

 

(2,182

)

(200

)

Payment of Oracea milestone fees

 

 

(1,000

)

Purchase of short-term investments

 

(48,640

)

(27,155

)

Sale or maturity of short-term investments

 

42,420

 

29,074

 

Net cash (used in) provided by investing activities

 

(9,142

)

333

 

Cash flows from financing activities:

 

 

 

 

 

Net proceeds from issuance of common stock

 

 

11,594

 

Net proceeds from the exercise of stock options

 

2,133

 

1,734

 

Net proceeds from the exercise of common stock warrants

 

376

 

 

Payment of preferred dividends

 

(2,028

)

(1,827

)

Principal payments on capital leases

 

(66

)

 

Net cash provided by financing activities

 

415

 

11,501

 

Net decrease in cash and cash equivalents

 

(15,149

)

(16,619

)

Cash and cash equivalents at beginning of period

 

46,493

 

26,219

 

Cash and cash equivalents at end of period

 

$

31,344

 

$

9,600

 

Supplemental disclosure of cash flow information:

 

 

 

 

 

Cash paid for interest

 

$

24

 

$

6

 

Accrued liability for capital leases

 

$

230

 

$

263

 

Accrued liability for capitalized product development milestone fees

 

$

 

$

670

 

Accrued liability for in-process research and development

 

$

 

$

100

 

Reversal of liability for UK income tax payable (see Note 1)

 

$

945

 

$

 

 

See accompanying notes to unaudited condensed consolidated financial statements.

 

6



 

COLLAGENEX PHARMACEUTICALS, INC.
AND SUBSIDIARIES

 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
September 30, 2007 and 2006
(dollars in thousands, except per share data)
(unaudited)

 

Note 1 — Basis of Presentation

 

The unaudited condensed consolidated financial statements included herein have been prepared by CollaGenex Pharmaceuticals, Inc. and subsidiaries, or the Company, pursuant to the rules and regulations of the Securities and Exchange Commission and in accordance with accounting principles generally accepted in the United States of America, or U.S. GAAP. Certain information and footnote disclosures normally included in the annual consolidated financial statements prepared in accordance with U.S. GAAP, have been condensed or omitted pursuant to such rules and the regulations of the Securities and Exchange Commission. These unaudited condensed consolidated financial statements should be read in conjunction with the Company’s 2006 audited consolidated financial statements and footnotes included in its Annual Report on Form 10-K for the year ended December 31, 2006.

 

The accompanying unaudited condensed consolidated financial statements include the results of operations of the Company and its majority-owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation.

 

In the opinion of the Company’s management, the accompanying unaudited condensed consolidated financial statements have been prepared on a basis substantially consistent with the audited consolidated financial statements for the year ended December 31, 2006 and contain adjustments, all of which are of a normal, recurring nature necessary to present fairly the Company’s consolidated financial position at September 30, 2007, the results of operations for the three and nine months ended September 30, 2007 and 2006, and the cash flows for the nine months ended September 30, 2007 and 2006. Interim results are not necessarily indicative of results anticipated for the full fiscal year.

 

The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Actual results could differ from those estimates.

 

Net Product Sales

 

The Company generally recognizes revenues for product sales upon shipment to wholesale customers, net of estimated returns and estimates for chargebacks, sales discounts and applicable wholesale distribution fees and rebates provided that collection is probable and no significant obligations remained. However, following the launch of a third party generic competitor to Periostat® in May 2005 and commencing with the second quarter of 2005, the Company began recognizing Periostat sales revenue based on product sales to end-users. For all other products sold, the Company records sales discounts, allowances, rebates and returns upon the recognition of product sales. The Company only accepts returns of damaged or expired products. The return allowance, when estimatable, is based on an analysis of the historical returns of the product and the Company considers current end user demand and wholesale and retail inventory levels. If product returns are not estimatable, the Company defers revenue recognition for all outstanding products in the wholesale and retail channel that are subject to return. Chargebacks, wholesale distribution fees and rebates are based on an analysis of the applicable agreements and historical experience. In addition, the Company also considers the volume and price of the product in the channel, trends in wholesaler and retailer inventory levels, conditions that might affect end-user demand (such as generic competition) and other relevant factors.

 

The Company currently utilizes a patient rebate program for Oracea® prescriptions. The Company accounts for these patient rebates as a reduction of net product sales.

 

7



 

Contract and License Revenues

 

Non-refundable, up-front contract and license fees are deferred and amortized to revenue over the related performance period. The Company estimates the performance period based on the specific terms of each of the license or contract agreements. The Company recognizes periodic payments over the period that the Company performs the related activities under the terms of the agreements. Revenue resulting from the achievement of milestone events stipulated in the agreements is recognized when the milestone is achieved if reliable, verifiable and objectively determinable evidence of fair value is established. If such evidence of fair value cannot be established, the total revenue resulting from any such agreement will be recognized over the total performance period of such agreement.

 

Pursuant to the Company’s Promotion and Cooperation Agreement, or the Promotion Agreement, with Primus Pharmaceuticals, Inc., or Primus, contract revenues for Alcortin, a prescription topical antifungal steroid combination and Novacort, a prescription topical steroid and anesthetic, are fee-based arrangements where contract revenue is earned as prescriptions are filled and recognized as a percentage of the gross profit earned by Primus. The Company does not take title to the inventory sold by Primus under the Promotion Agreement.

 

Grant Revenues

 

During 2005, the Company received a grant from the National Institutes of Health, or NIH, to fund additional research by the Company and its collaborators on the anti-inflammatory effects of incyclinide. The Company expenses such research expenditures as they are incurred and recognizes grant revenue when earned for the portion of the expenditures that are reimbursable by the NIH. The Company recognized $60 and $211 in grant revenues for the three and nine months ended September 30, 2007 and $211 and $377 in grant revenues for the three and nine months ended September 30, 2006.

 

Research and Development

 

Research and product development costs are expensed as incurred. Research and development expenses consist primarily of personnel costs and funds paid to third parties for the provision of services and materials for drug development, manufacturing and formulation enhancements, clinical trials (including clinical trials conducted after FDA approval of a product), statistical analysis and report writing and regulatory compliance costs, including governmental filing fees.

 

As described above, some of the Company’s research and development is conducted by third parties, including contract research and development service providers. At the end of each quarter, the Company compares the payments made to each service provider to the estimated progress toward completion of the research or development objectives. Such estimates are subject to change as additional information becomes available. Depending on the timing of payments to the service providers and the progress that the Company estimates has been made as a result of the service provided, the Company may record net prepaid or accrued expense relating to these costs.

 

Costs to acquire in-process research and development projects and technologies which have not achieved technical feasibility at the date of acquisition are expensed as research and development expense as incurred. The Company expensed $2,182 of in-process research and development for the nine months ended September 30, 2007 and $300 for the nine months ended September 30, 2006.

 

Inventories

 

Inventories are stated at the lower of cost or market. Cost is determined using the first-in, first-out method. Critical accounting estimates and assumptions related to inventory carrying values are evaluated periodically and consider the saleable quantities of inventory versus quantities of inventory on-hand.

 

The Company classifies costs relating to the manufacture of product inventory and samples in advance of a new product launch as research and development expense until the product is approved by the Food and Drug Administration, or FDA. Following FDA approval, the Company’s policy is to capitalize any inventory costs that were not previously recognized as a research and development expense.

 

8



 

Stock-Based Compensation

 

The Company recognizes the fair value of stock-based compensation awards in the Company’s consolidated financial statements using the modified prospective method. The Company applies the Black-Scholes option pricing model to determine the fair value of stock options on the date of grant and estimates key assumptions that are important elements in the model, such as the expected stock-price volatility and expected stock option life. The Company’s estimates of these key assumptions and expected forfeiture rates are based on historical data and judgment regarding market trends and factors. These estimates are not intended to predict actual future events or the value ultimately realized by individuals who receive equity awards.

 

Cash, Cash Equivalents and Short-Term Investments

 

The Company considers all highly liquid investments with an original maturity of three months or less at the date of acquisition to be cash equivalents. Cash equivalent investments are held at amortized cost, which approximates fair value. All short-term investments have original maturity dates of between three months and one year. The Company’s short-term investments are primarily composed of commercial paper, certificates of deposit and government notes. At September 30, 2007, all of the Company’s short-term investments, carried at fair value, were classified as available-for-sale with unrealized gains and losses included as a separate component of stockholders’ equity.

 

The accumulated net unrealized gain on short-term investments at September 30, 2007 was $2. The accumulated net unrealized gain on short-term investments was $7 at December 31, 2006.

 

 

 

Amortized

 

Gross

 

Gross

 

 

 

September 30, 2007

 

Cost

 

unrealized gain

 

unrealized loss

 

Fair value

 

Certificates of Deposit

 

$

7,001

 

$

 

$

(3

)

$

6,998

 

U.S. Agency Notes(1)

 

7,435

 

3

 

 

7,438

 

Commercial Paper

 

11,114

 

2

 

 

11,116

 

Total

 

$

25,550

 

$

5

 

$

(3

)

$

25,552

 

 

 

 

Amortized

 

Gross

 

Gross

 

 

 

December 31, 2006

 

Cost

 

unrealized gain

 

unrealized loss

 

Fair value

 

Certificates of Deposit

 

$

7,196

 

$

 

$

(1

)

$

7,195

 

U.S. Agency Notes(1)

 

10,351

 

7

 

 

10,358

 

Commercial Paper

 

1,783

 

1

 

$

 

1,784

 

Total

 

$

19,330

 

$

8

 

$

(1

)

$

19,337

 

 


(1) U.S. Agency notes are comprised of Fannie Mae, Freddie Mac, Farmer Mac, Federal Farm Credit and Federal Home Loan bank. If held to maturity, these holdings allow the issuer to settle the securities at a price no less than the amortized cost.

 

Accounting Change

 

On January 1, 2007, the Company adopted the Financial Accounting Standards Board, or FASB, Interpretation No. 48, Accounting for Uncertainty in Income Taxes, or FIN 48. FIN 48 clarifies the accounting for uncertainty in income taxes recognized in an enterprise’s financial statements in accordance with SFAS No. 109, Accounting for Income Taxes. FIN 48 prescribes a recognition threshold and measurement for financial statement recognition and measurement of a tax position reported or expected to be reported on a tax return. FIN 48 also provides guidance on derecognition, classification, interest and penalties, accounting in interim periods, disclosure, and transition. Prior to the adoption of FIN 48, the Company’s policy was to recognize tax benefits of uncertain tax positions only if it was “probable” that the position would be sustained. FIN 48 requires application of a “more likely than not” threshold to the recognition and derecogntion of tax positions. As a result of the adoption of FIN 48, retained earnings increased in the amount of $945 and accrued expenses decreased by the same amount as of January 1, 2007 (see Note 10).

 

9



 

The Company and its subsidiaries file income tax returns in the U.S. federal jurisdiction and in various states. The Company has tax net operating loss and credit carryforwards that are subject to examination for a number of years beyond the year in which they are utilized for tax purposes. Since a portion of these carryforwards will be utilized in the future, many of these attribute carryforwards may remain subject to examination. The Company’s policy is to record interest and penalties on uncertain tax positions as income tax expense. At September 30, 2007, the Company has no amounts recorded for uncertain tax positions, interest or penalties in the accompanying consolidated financial statements.

 

Recently Issued Accounting Pronouncements

 

In September 2006, the FASB issued Statement of Financial Accounting Standards, or SFAS, Statement No. 157, “Fair Value Measurements”, or SFAS 157. SFAS 157 clarifies the definition of fair value, establishes a framework for measuring fair value and expands the disclosures on fair value measurements. SFAS 157 is effective for the Company beginning January 1, 2008. The Company is currently evaluating the impact, if any, of SFAS 157 adoption on its consolidated financial statements.

 

In February 2007, the FASB issued SFAS No.159, The Fair Value for Financials Assets and Financial Liabilities or SFAS No. 159. SFAS No. 159 permits entities to choose to measure financial assets and liabilities, with certain exceptions, at fair value at specified election dates. A business entity shall report unrealized gains and losses on items for which the fair value option has been elected in earnings at each subsequent reporting date. SFAS No. 159 is effective as of the beginning of an entity’s first fiscal year that begins after November 15, 2007. The Company is currently evaluating the impact, if any, SFAS No. 159 will have on its consolidated financial statements.

 

In June 2007, the Emerging Issues Task Force (“EITF”) reached a final consensus on EITF Issue No. 07-3, “Accounting for Nonrefundable Advance Payments for Goods or Services to Be Used in Future Research and Development Activities” (“EITF 07-3”). EITF 07-3 is effective for fiscal years beginning after December 15, 2007.  EITF 07-3 requires that non-refundable advance payments for future research and development activities should be capitalized until the goods have been delivered or related services have been performed.  Adoption is on a prospective basis and could impact the timing of expense recognition for agreements entered into after December 31, 2007.  The Company does not expect the adoption of EITF 07-3 to have a significant impact on the consolidated financial statements.

 

Note 2 — Concentration of Credit and Segment Information

 

The Company invests its excess cash in money market funds with major U.S. financial institutions, commercial paper, certificates of deposit and government notes, based on its investment guidelines designed to protect the safety and liquidity of these investments.

 

The Company currently contracts with a single source for the manufacturing of Oracea capsules and Periostat tablets and has an agreement with a single company to supply the active ingredient in Oracea and Periostat. A single company also provides all warehousing and logistics services to the Company.

 

As indicated in the table below, three customers accounted for 92% and 87%, respectively of net product sales for the three months ended September 30, 2007 and 2006. The same three customers accounted for 91% and 88% of net product sales during the nine months ended September 30, 2007 and 2006.

 

 

 

% of Net Product Sales

 

 

 

Three Months Ended

 

 

 

September 30,

 

Customer

 

2007

 

2006

 

Cardinal Health

 

40

%

42

%

McKesson

 

39

%

33

%

AmerisourceBergen

 

13

%

12

%

Total

 

92

%

87

%

 

 

 

% of Net Product Sales

 

 

 

Nine Months Ended

 

 

 

September 30,

 

Customer

 

2007

 

2006

 

Cardinal Health

 

42

%

46

%

McKesson

 

36

%

29

%

AmerisourceBergen

 

13

%

13

%

Total

 

91

%

88

%

 

10



 

As indicated in the table below three customers accounted for 94% of gross trade accounts receivable balance at September 30, 2007 and at December 31, 2006.

 

 

 

% of Gross Trade Accounts

 

 

 

Receivable Balance at

 

 

 

September 30,

 

December 31,

 

Customer

 

2007

 

2006

 

Cardinal Health

 

46

%

58

%

McKesson

 

39

%

29

%

AmerisourceBergen

 

9

%

7

%

Total

 

94

%

94

%

 

The Company operates as one business that is managed by a single management team reporting to the chief executive officer. The Company does not prepare discrete financial information with respect to separate product or product candidate areas or by location and does not have separately reportable segments. During each of the three and nine months ended September 30, 2007 and 2006, the Company’s total net revenues were comprised of the following:

 

 

 

Three Months Ended

 

 

 

September 30,

 

 

 

2007

 

2006

 

Oracea

 

82

%

40

%

Other dermatology

 

10

%

27

%

Dental

 

7

%

30

%

Grant revenue

 

1

%

3

%

Total

 

100

%

100

%

 

 

 

Nine Months Ended

 

 

 

September 30,

 

 

 

2007

 

2006

 

Oracea

 

80

%

17

%

Other dermatology

 

11

%

34

%

Dental

 

9

%

46

%

Grant revenue

 

%

3

%

Total

 

100

%

100

%

 

Note 3 — Stock-Based Compensation

 

At September 30, 2007, the Company had one active stock-based employee compensation plan. Stock option awards to employees are granted with an exercise price equal to the fair market value of the Company’s common stock on the date of grant. The option awards typically have a term of ten years and generally vest over a period ranging from two to five years. Certain options are subject to accelerated vesting if there is a change in control (as defined in the plan and change of control agreements, if applicable).

 

Stock-based compensation for the three and nine months ended September 30, 2007 and 2006 are as follows:

 

11



 

 

 

Three Months Ended

 

 

 

September 30,

 

 

 

2007

 

2006

 

Research and development

 

$

139

 

$

111

 

Selling, general and administrative

 

579

 

739

 

Total

 

$

718

 

$

850

 

 

 

 

Nine Months Ended

 

 

 

September 30,

 

 

 

2007

 

2006

 

Research and development

 

$

383

 

$

317

 

Selling, general and administrative

 

1,657

 

2,211

 

Total

 

$

2,040

 

$

2,528

 

 

No amount of stock-based compensation cost has been capitalized into inventory or other assets during the three and nine months ended September 30, 2007 and 2006.

 

Certain options granted in 2003 have been amortized at an accelerated rate versus the contractual vesting period of such options as these options are performance-based and it was anticipated that the performance criteria would be met prior to straight-line vesting. Such options were fully amortized at December 31, 2006.

 

In May 2006, the Company accelerated the vesting of certain options held by a former member of the Company’s Board of Directors. Accordingly, a charge of $92 was recorded during the nine months ended September 30, 2006 to reflect the fair value of such options on the date of modification.

 

The following table summarizes activity under all stock option plans.

 

 

 

Nine Months Ended

 

 

 

September 30,

 

(dollars in thousands, except per share data)

 

2007

 

2006

 

Weighted-average fair value of options granted per share

 

$

8.55

 

$

7.70

 

Intrinsic value of options exercised

 

$

1,132

 

$

795

 

 

At September 30, 2007, the value of the unvested portion of all outstanding stock-related awards was $7,617 which the Company expects to amortize and recognize as compensation expense over the weighted-average service period of approximately two years.

 

The amount of cash received during the nine months ended September 30, 2007 and 2006 from the exercise of options was $2,133 and $1,734, respectively. No related tax benefit from the exercise of such options was realized as a result of the Company’s net operating loss carryforwards and full valuation allowance.

 

The Company received $376 in cash during the nine months ended September 30, 2007 as a result of the exercise of 40,000 warrants on June 28, 2007. As of September 30, 2007, the Company had no outstanding warrants.

 

The fair values of the options granted during the nine months ended September 30, 2007 and 2006 were determined using the Black-Scholes option pricing model, which incorporates various assumptions. The risk-free rate of interest for the average contractual life of the option is based on U.S. Government Securities Treasury Constant Maturities. Expected volatility is based on the historical daily volatility of the Company’s common stock. The expected life is determined using the short-cut method permitted under Staff Accounting Bulletin No. 107, Share-Based Payment. The expected dividend rate yield is zero because the Company currently does not pay or expect to pay dividends to common stockholders.

 

The following are the weighted average assumptions used during the respective periods:

 

12



 

 

 

Three Months Ended

 

 

 

September 30,

 

 

 

2007

 

2006

 

Expected life in years

 

6.50

 

6.50

 

Risk-free interest rate

 

4.43

%

4.77

%

Volatility

 

56.77

%

65.00

%

Expected dividend yield

 

 

 

 

 

 

Nine Months Ended

 

 

 

September 30,

 

 

 

2007

 

2006

 

Expected life in years

 

6.50

 

6.50

 

Risk-free interest rate

 

4.66

%

4.63

%

Volatility

 

61.15

%

68.90

%

Expected dividend yield

 

 

 

 

Stock option activity during the nine months ended September 30, 2007 was as follows:

 

 

 

 

 

Weighted

 

Average

 

 

 

 

 

 

 

Average

 

Remaining

 

Aggregate

 

 

 

Number of

 

Exercise Price

 

Contractual

 

Intrinsic

 

 

 

Shares

 

per Share

 

Term (years)

 

Value (1)

 

Outstanding at December 31, 2006

 

3,478,590

 

$

9.69

 

 

 

 

 

Options granted

 

498,710

 

13.58

 

 

 

 

 

Options exercised

 

(240,922

)

8.85

 

 

 

 

 

Options forfeited or cancelled

 

(54,403

)

12.70

 

 

 

 

 

Outstanding at September 30, 2007

 

3,681,975

 

$

10.23

 

6.07

 

$

4,602

 

Unvested at September 30, 2007

 

1,453,598

 

$

10.75

 

8.22

 

$

2,574

 

Exercisable at September 30, 2007

 

2,228,377

 

$

9.89

 

4.66

 

$

2,028

 

 


(1)             The aggregate intrinsic value was calculated based on the positive difference between the closing sales price of the Company’s common stock ($8.98 per share) on September 28, 2007 and the exercise prices of the underlying options.

 

Note 4 — Inventories

 

Inventories at September 30, 2007 and December 31, 2006 consist of the following:

 

 

 

September 30,

 

December 31,

 

 

 

2007

 

2006

 

Raw materials

 

$

838

 

$

978

 

Work in processs

 

227

 

339

 

Finished goods

 

941

 

642

 

Total

 

$

2,006

 

$

1,959

 

 

The Company recorded a charge of $37 to cost of product sales related to excess inventories of the Atrix and Pandel products during the three months ended September 30, 2007. During the three and nine months ended September 2006, the Company recorded a charge to cost of product sales of $160 and $250 related to excess inventories. During the three months ended September 30, 2007, the Company recorded a charge of $180 to cost of product sales related to validation costs from the manufacturer of the Company’s inventory.

 

13



 

Note 5— Intangible Assets, Net

 

Intangible assets, net at September 30, 2007 and December 31, 2006 consist of the following:

 

 

 

September 30,

 

December 31,

 

 

 

2007

 

2006

 

Oracea milestone fees

 

$

1,670

 

$

1,670

 

Accumulated amortization

 

(139

)

(56

)

Oracea milestone fees, net

 

$

1,531

 

$

1,614

 

Atrix acquired product rights

 

$

1,876

 

$

1,876

 

Accumulated amortization

 

(1,825

)

(1,608

)

Atrix acquired product rights, net

 

$

51

 

$

268

 

Total intangible assets, net

 

$

1,582

 

$

1,882

 

 

In August 2001, the Company signed a license agreement with Atrix Laboratories, Inc. (now known as Tolmar Inc., a subsidiary of Technofarma, S.A.), for the rights to market Atridox®, Atrisorb FreeFlow® and Atrisorb-D® in the United States. On May 14, 2007, the Company received written notice of termination effective November 14, 2007 of the Company’s License Agreement with Tolmar Inc. The amortization of acquired product rights has been adjusted to coincide with the termination date of the contract.

 

Oracea milestone fees represent the unamortized component of Oracea formulation milestones paid post-FDA approval of Oracea and are being amortized on a straight-line basis over a fifteen year period commencing in July 2006.

 

Amortization expense, which is included in cost of product sales, was $105 and $300 for the three and nine months ended September 30, 2007 and $83 and $284 for the three and nine months ended September 30, 2006.

 

Note 6 — Line of Credit

 

On October 9, 2006, the Company entered into a Sixth Loan Modification Agreement with Silicon Valley Bank. Pursuant to the terms of this agreement, the expiration date of the amended credit facility has been extended to October 9, 2008. Under the amended credit facility, the Company may borrow up to the lesser of (i) $10,000 or (ii) 80% of eligible receivables plus certain specified amounts, subject to reduction during the period October 9, 2006 through December 31, 2007. The amount available to the Company is reduced by any outstanding letters of credit that may be issued under the amended credit facility in amounts totaling up to $2,000. As the Company pays down amounts under any letter of credit, the amount available to it under the credit facility increases. The Company is not obligated to draw down any amounts under the amended credit facility and any borrowings shall bear interest, payable monthly, at Silicon Valley Bank’s prime rate, or 7.75%, at September 30, 2007. Under the Sixth Loan Modification Agreement, the Company is charged an unused line credit fee of 0.25% per annum. In addition, under the amended credit facility, the Company is subject to financial covenants that require the Company to maintain certain minimum liquidity and tangible net worth levels on a quarterly basis. During the nine months ended September 30, 2007 and 2006, the Company’s unused line of credit fee was $45 and $18, respectively. As of September 30, 2007 the Company had no borrowings outstanding.

 

14



 

Note 7— Contract and License Revenues

 

The Company recorded contract and license revenues of $314 and $826 for the three and nine months, ended September 30, 2007, respectively, and $431 and $1,084 for the three and nine months ended September 30, 2006, respectively. In June 2005, the Company entered into the Promotion Agreement with Primus, under which the Company promotes Alcortin, a prescription topical antifungal steroid combination, and Novacort, a prescription topical steroid and anesthetic. Under the Promotion Agreement, the Company receives a percentage of the gross profit arising from prescriptions written by dermatology professionals (or offices) that result in sales of the products in the United States. Through June 30, 2006, the majority of marketing expenses, excluding sales force compensation and sample product costs, related to the promotion of the Primus products were funded by Primus and the majority of product sample costs and all sales force compensation were funded by the Company. Effective July 1, 2006, the Company and Primus amended the Promotion Agreement. As a result of the amendment, sample expenses and marketing costs, excluding sales force compensation, are funded 60% by the Company and 40% by Primus.

 

On December 18, 2006, the Company executed a License and Supply Agreement with MediGene AG, or MediGene, a corporation existing under the laws of Germany, that became effective on January 1, 2007. Under this agreement, MediGene has the right to manufacture, register, market and sell Oracea in the European Union, certain contiguous countries and Russia. MediGene may exercise its right to manufacture Oracea at any time during the term of the agreement upon twelve months notice to the Company. During the nine months ended September 30, 2007, the Company classified the up front non-refundable fee of $5,000 as non-current deferred licensing revenue. In accordance with the Company’s revenue recognition policy, the Company would begin amortizing this deferred revenue to revenue over the term of the agreement once EU approval for Oracea has been received. Additionally, the Company may be entitled to an additional $7,500 in milestone payments upon the achievement of certain annual sales thresholds achieved by MediGene. In addition, the Company will receive an agreed upon transfer price and a royalty of 12% of annual net sales up to $10,000 and 15% of annual net sales in excess of $10,000 in the specified territories. The Company’s application for European marketing authorization for Oracea was recently referred to the Committee for Medicinal Products for Human Use, or CHMP. Referral to the CHMP may be a lengthy process and the Company cannot predict when, or if, this body will approve the Company’s application.

 

In October 2002, the Company announced the execution of a license agreement with Medtronic, Inc., or Medtronic, involving the Company’s IMPACS compounds, pursuant to which Medtronic obtained an exclusive, worldwide license to use the compounds and certain related patent technology to treat aortic aneurysms and other forms of vascular disease with medical devices. This program is still active. In an amendment to the Medtronic License dated January 27, 2007, the Company agreed to narrow the scope of Medtronic’s rights, to provide that the license shall become non-exclusive if certain milestones are not timely met, and to accelerate the timing of the first milestone payment of $250 upon execution of the amendment. During the nine months ended September 30, 2007, the Company received the $250 milestone payment and has classified this in non-current deferred licensing revenue in the accompanying condensed consolidated balance sheet. Further milestone payments of $500 and $2,000 respectively, become due upon first human use and first commercial sale, of a product incorporating IMPACS technology. Medtronic must also pay royalties based on a percentage of net sales of such a product. Neither the Company nor Medtronic have developed a timetable for clinical development or commercial launch of any product.

 

Note 8 — Legal Proceedings

 

The Company is involved in, or has been involved in, arbitrations or various other legal proceedings that arise from the normal course of business. The Company cannot predict the timing or outcome of these claims and other proceedings. At September 30, 2007, the Company is not involved in any arbitration and/or other legal proceedings that it expects to have a material adverse effect on the business, financial condition, results of operations or liquidity of the Company. All legal costs are expensed as incurred.

 

Note 9 — Legal Expenses to Defend Periostat Patents

 

Under the Company’s license agreement with The State University of New York at Stony Brook, or SUNY, covering Periostat and Oracea, the Company is entitled to deduct costs incurred to defend its patents from current and future royalties due to SUNY on net sales of Oracea and Periostat. The cumulative legal patent defense, litigation and settlement costs incurred during the litigation period through September 30, 2007 currently exceeds the amount of the royalties earned by SUNY, since the inception of litigation, by $2,902. This excess amount, which has been previously expensed, may be available to offset future royalties earned by SUNY, if any, on sales of products based on the SUNY technology. The Company recorded $215 and $764 in product royalty expense and credited legal expense for $215 and $764 related to previously expensed legal fees for the three and nine months ended September 30, 2007. Accordingly, $215 and $764 were deducted from royalty payments earned by SUNY during the three and nine months ended September 30, 2007. The

 

15



 

Company recorded $183 and $335 in product royalty expense and credited legal expense for $183 and $335 related to previously expensed legal fees for the three and nine months ended September 30, 2006. Accordingly, $183 and $335 were deducted from royalty payments earned by SUNY during the three and nine months ended September 30, 2006.

 

Note 10 — Accrued Expenses

 

Accrued expenses at September 30, 2007 and December 31, 2006 consist of the following:

 

 

 

September 30,

 

December 31,

 

 

 

2007

 

2006

 

Research and development costs

 

$

2,215

 

$

1,257

 

Payroll and related costs

 

2,242

 

3,041

 

Sales and marketing costs

 

1,277

 

786

 

Product returns

 

1,490

 

996

 

Patient rebates

 

435

 

78

 

Government rebates and distribution fees

 

129

 

80

 

Managed Care rebates

 

280

 

 

Professional and consulting fees

 

190

 

132

 

State and franchise taxes

 

158

 

161

 

Foreign taxes (1)

 

 

945

 

Other

 

125

 

98

 

Total

 

$

8,541

 

$

7,574

 

 


(1)             In November 2004, the Company sold its U.K. and European dental assets to Alliance Pharma plc, a U.K. specialty pharmaceuticals company. As part of this sale in 2004, the Company recorded a liability of $945 within accrued expenses for anticipated U.K. income taxes due on this sale. As described in Note 1, the Company adopted FIN 48 on January 1, 2007. As a result of the adoption, this liability was reversed on January 1, 2007, as the threshold for this tax uncertainty was above more-likely-than not. On January 19, 2007, the Company received a notice from the U.K. taxing authorities stating that no amendments were needed to the Company’s previously filed tax return. Accordingly, no additional income taxes were due related to this transaction.

 

Note 11 — Commitments

 

On July 17, 2007, the Company entered into a capital lease for certain telecommunication equipment. The lease term is thirty-six months with annual payments of $22. At September 30, 2007, the gross amount of equipment related to this capital lease amounted to $54.

 

Note 12 — Common Stock Offering

 

In November 2006, the Company raised $42,500 in a public offering, net of placement agency fees and all related offering expenses. In December 2005 and January 2006, the Company raised $15,500 and $11,600 respectively, in a public offering, net of placement agency fees and all related offering expenses.

 

16



 

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

 

Our management’s discussion and analysis of our financial condition and results of operations include the identification of certain trends and other statements that may predict or anticipate future business or financial results. There are important factors that could cause our actual results to differ materially from those indicated. See “Part II, Item 1A., Risk Factors.”

 

Overview

 

CollaGenex Pharmaceuticals, Inc. and subsidiaries is a specialty pharmaceutical company currently focused on developing and marketing innovative proprietary medical therapies to the dermatology market. We currently market four prescription pharmaceutical products to the dermatology market through our professional dermatology sales force and generate revenues from four other prescription pharmaceutical products that we continue to sell to the dental market. In May 2006, the U.S. Food and Drug Administration, or the FDA, granted us marketing approval for Oracea® for the treatment of inflammatory lesions (papules and pustules) of rosacea in adult patients. Oracea is the first FDA approved, orally-administered, systemically-delivered drug to treat rosacea. In July 2006, we launched Oracea to the U.S. dermatology community.

 

Our strategy is to become a leading developer and marketer of innovative prescription pharmaceutical products to the dermatology market. We intend to continue to market our current products, including Oracea, and develop and launch new products based on our proprietary platform technologies as well as other technologies. Our lead development candidates are: COL-118, a topical compound that we are developing for the treatment of erythema (skin redness) associated with dermatological conditions. We recently reported favorable results from a Phase II clinical trial of this compound and we are in discussions with FDA concerning the conclusion of Phase II and the design and timing of Phase III clinical trials, which we expect to initiate in the middle of 2008; becocalcidiol, a recently licensed vitamin D analogue for the topical treatment of psoriasis; and Restoraderm®, a foam-based, topical dermal drug delivery system, which is currently in formulation development.

 

Our marketed dermatology products are: Oracea; Pandel®, a prescription corticosteroid we licensed in 2002 from Altana Inc., a member of the Nycomed Group; Alcortin™, a prescription topical antifungal steroid combination; and Novacort™, a prescription topical steroid and anesthetic. In June 2005, we executed a Promotion and Cooperation Agreement with Primus Pharmaceuticals Inc., or Primus, to market Alcortin and Novacort to dermatologists. On February 1, 2007, we received written notice of termination of the Sublicense Agreement relating to Pandel. Effective November 1, 2007, we will no longer generate sales from the Pandel product.

 

Our original dental product, Periostat®, is an orally-administered, prescription pharmaceutical product that was approved by the FDA in September 1998 for the treatment of adult periodontitis. On May 20, 2005, we terminated our dental sales force and promotional activities for Periostat following the introduction of a third party generic version of the product. We also discontinued the promotion of our other dental products on May 20, 2005. We continue to generate sales from Periostat and three other dental products, which include Atridox®, Atrisorb FreeFlow® and Atrisorb-D®, also referred to as the Atrix Products, each of which is licensed from Tolmar Inc., a subsidiary of Tecnofarma, S.A. Effective November 14, 2007, our License Agreement with Tolmar, Inc. will terminate and we will no longer generate sales from the Atrix Products.

 

In addition to our marketed products, we have a pipeline of product candidates in clinical and preclinical development. These products are based on our proprietary platform technologies, SansRosa® and Restoraderm, or are licensed from third parties.

 

We were founded in 1992 and completed an initial public offering of our common stock in 1996. Although we achieved net income for the years ended December 31, 2004, 2003 and 2002, we have incurred losses in every other year since inception and have an accumulated deficit of $134.4 million at September 30, 2007. We do not expect to generate a profit for the year ending December 31, 2007.

 

Our Technology

 

IMPACS (Inhibitors of Multiple Proteases And CytokineS) are a group of compounds that demonstrate a range of anti-inflammatory activities as well as the ability to inhibit the breakdown of connective tissue. Periostat and Oracea are our first FDA-approved IMPACS products. Our IMPACS technology is licensed on a perpetual basis from the Research

 

17



 

Foundation of the State University of New York at Stony Brook, or SUNY. SUNY also conducts research and development on other potential applications of this technology on a project basis.

 

Our SansRosa technology, which we acquired in connection with the acquisition of SansRosa Pharmaceutical Development Inc., or SansRosa, in December 2005, is a class of compounds that have shown promise in reducing the redness associated with rosacea, and we intend to formulate and develop a topical treatment for erythema based on one or more of these compounds.

 

Our Restoraderm technology is a proprietary, foam-based, topical drug delivery technology that originated from a Swedish collaborator. We have acquired all rights, title and interest to the Restoraderm technology. We have formulated various prescription and over the counter products based on the Restoraderm technology. We do not currently have a timetable for either the initiation of clinical development or the launch of any Restoraderm products.

 

Our becocalcidiol product candidate uses technology covered by various patents and patent applications licensed from QuatRx Pharmaceuticals Company, or QuatRx, pursuant to a Sub-License Agreement, or the Sub-License Agreement.

 

Significant Recent Developments

 

On August 23, 2007, we announced results of a Phase II dose-finding study designed to evaluate the safety and efficacy of COL-118 for the treatment of erythema. The Phase II clinical study demonstrated a highly statistically significant dose-response relationship of COL-118 in the reduction of erythema with a side effect profile similar to placebo. We are in discussions with FDA concerning the conclusion of Phase II and the design and timing of Phase III clinical trials, which we expect to initiate in the middle of 2008.

 

On March 29, 2007, we announced that we had commenced enrollment of patients in a 40 mg cohort of our Phase II double-blinded, placebo-controlled, dose-finding clinical trial to determine the appropriate dose for Phase III testing of incyclinide in the treatment of acne. On May 2, 2007, we learned that one patient had experienced apparent significant photo-toxicity, a known side effect of tetracyclines, while participating in the 40 mg cohort and we suspended enrollment of all new patients in this study. On May 7, 2007, we learned of another patient who had experienced apparent photo-toxicity and we announced that we had discontinued treatment of all enrolled patients.

 

On September 26, 2007, we announced results of a Phase II dose-finding study designed to evaluate the safety and determine the therapeutic range of incyclinide for the treatment of rosacea. The study demonstrated that incyclinide was well tolerated with most adverse events being mild to moderate. However, the patients administered incyclinide did not demonstrate greater reduction in inflammatory lesions than the patients on placebo at any time point during the study and we discontinued all development work on incyclinide for a rosacea indication.

 

On November 6, 2007, we announced that, following a detailed cost, benefit and risk analysis in the fourth quarter of 2007, we had decided to discontinue all development work on incyclinide for an acne indication in order to focus our resources and energies on those projects in our pipeline that we believe have the greatest potential.

 

18



 

Results of Operations

 

Comparison of the Three Months Ended September 30, 2007 and September 30, 2006

 

Revenues

 

Revenues

 

 

 

 

 

Change

 

(dollars in thousands)

 

2007

 

2006

 

$

 

%

 

Net Oracea Product Sales

 

$

13,080

 

$

2,236

 

$

10,844

 

485.0

%

Other Net Product Sales

 

2,479

 

2,755

 

(276

)

(10.0

)%

Total Net Product Sales

 

15,559

 

4,991

 

10,568

 

211.7

%

Contract Revenues

 

267

 

419

 

(152

)

(36.3

)%

License Revenues

 

47

 

12

 

35

 

291.7

%

Grant Revenue

 

60

 

211

 

(151

)

(71.6

)%

Total Revenues

 

$

15,933

 

$

5,633

 

$

10,300

 

182.9

%

 

During the three months ended September 30, 2007, total net product sales which included net sales of Oracea, Pandel, Periostat and the Atrix Products, increased $10.6 million, or 211.7%, as compared to the three months ended September 30, 2006, due primarily to sales from Oracea, which was launched in July 2006. Net revenues from dermatological products were 92.3% of total net revenues in the three months ended September 30, 2007 compared to 66.3% for the three months ended September 30, 2006. Total deductions from gross sales for estimated product returns, trade cash discounts, managed care rebates, government and patient rebates and wholesale distribution fees for Oracea were approximately 14.7% of gross sales during the three months ended September 30, 2007 compared to 37.8% during the three months ended September 30, 2006. Prescriptions for Oracea as reported by an independent industry data source were approximately 100,504 during the three months ended September 30, 2007, representing a 252% increase in prescriptions compared to 28,545 prescriptions during the three months ended September 30, 2006. At September 30, 2007, Oracea wholesaler inventory level was approximately 4.1 weeks of sales as compared to approximately 3.3 weeks of sales at June 30, 2007.

 

Effective November 1, 2007, our Sublicense Agreement with Altana Inc., will terminate and we will no longer generate other net product sales from the Pandel product. Effective November 14, 2007, our License Agreement with Tolmar, Inc. will terminate and we will no longer generate sales from the Atrix Products.

 

Cost of Product Sales

 

Cost of product sales for the three months ended September 30, consist of the following:

 

Cost of Product Sales

 

 

 

 

 

Change

 

(dollars in thousands)

 

2007

 

2006

 

$

 

%

 

Manufacturing Costs

 

$

1,009

 

$

710

 

$

299

 

42.1

%

Product Royalties

 

1,250

 

549

 

701

 

127.7

%

Amortization of Licensing Fees

 

104

 

67

 

37

 

55.2

%

Cost of Product Sales

 

$

2,363

 

$

1,326

 

$

1,037

 

78.2

%

Percent of Net Product Sales

 

15.2

%

26.6

%

 

 

 

 

 

Manufacturing costs include contract manufacturing costs (Periostat and Oracea), transfer price (Pandel and the Atrix Products), manufacturing facility FDA validation costs, costs associated with excess inventories, overhead costs and internal costs.

 

19



 

Under our license agreement with SUNY, covering Periostat and Oracea, we are entitled to deduct prior legal costs incurred to defend SUNY’s patents from current and future royalties due SUNY on net sales of products based on SUNY technology. During the three months ended September 30, 2007, we recorded $215 in product royalty expense and credited legal expense for $215 related to previously expensed legal fees. Accordingly, $215 was deducted from royalty payments earned by SUNY during the three months ended September 30, 2007. During the three months ended September 30, 2006, we recorded $183 in product royalty expense and credited legal expense for $183 related to previously expensed legal fees. Accordingly, $183 was deducted from royalty payments earned by SUNY during the three months ended September 30, 2006. (see Note 9)

 

Cost of product sales increased $1.0 million during the three months ended September 30, 2007 compared to the three months ended September 30, 2006 due primarily to a significant increase in Oracea sales as well as approximately $180,000 in manufacturing development costs incurred during the three months ended September 30, 2007. Cost of product sales as a percent of net product sales was 15.2% for the three months ended September 30, 2007 and 26.6% for the three months ended September 30, 2006. The decrease in the cost of product sales as a percent of net product sales during the three months ended September 30, 2007 is primarily due to the addition of Oracea sales, which have higher gross margins than our other products.

 

Effective November 1, 2007, our Sublicense Agreement with Altana Inc. will terminate and we will no longer generate other net product sales from the Pandel product. As part of the termination agreement, we expect to receive $1.7 million from Altana Inc. that will be credited to cost of product sales during the fourth quarter of 2007.

 

Research and Development

 

Research and development for the three months ended September 30, consist of the following:

 

Research and Development

 

 

 

 

 

Change

 

(dollars in thousands)

 

2007

 

2006

 

$

 

%

 

incyclinide

 

$

1,268

 

$

2,306

 

$

(1,038

)

(45.0

)%

COL-118

 

1,283

 

119

 

1,164

 

978.2

%

Oracea

 

686

 

481

 

205

 

42.6

%

becocalcidiol

 

212

 

 

212

 

N/A

 

Internal and Other Costs

 

1,026

 

1,085

 

(59

)

(5.4

)%

Total Research and Development

 

$

4,475

 

$

3,991

 

$

484

 

12.1

%

 

Internal and other costs include personnel costs, stock option expense, regulatory compliance costs and other project development costs and other departmental costs.

 

Research and development expenses consist primarily of costs incurred for services and materials for drug development, manufacturing and formulation enhancements, clinical trials, purchased in-process research and development, statistical analysis and report writing and regulatory compliance costs (including drug approval submission and filing fees).

 

We estimate that future development and clinical costs associated with COL-118 will be approximately $18 to $22 million. It is premature to estimate future development and clinical costs for becocalcidiol. We are currently conducting formulation and stability work on products incorporating our Restoraderm technology, and we are reviewing product options and the timetable associated with clinical development or commercialization.

 

On September 26, 2007 and November 6, 2007, we announced that we had discontinued all development work on incyclinide for rosacea and acne indications, respectively.

 

During the fourth quarter of 2007, we expect to incur cancellation fees and other termination costs associated with the discontinuation of the incyclinide acne and rosacea development projects.

 

20



 

 Selling, General and Administrative

 

Selling, general and administrative for the three months ended September 30, consist of the following:

 

Selling, General and Administrative

 

 

 

 

 

Change

 

(dollars in thousands)

 

2007

 

2006

 

$

 

%

 

Marketing Expense

 

$

4,411

 

$

3,934

 

$

477

 

12.1

%

Selling Expense

 

4,009

 

4,141

 

(132

)

(3.2

)%

Corporate & Administrative Expense

 

1,914

 

1,780

 

134

 

7.5

%

Stock Option Expense

 

579

 

739

 

(160

)

(21.7

)%

Total Selling, General and Administrative

 

$

10,913

 

$

10,594

 

$

319

 

3.0

%

 

Marketing expenses include personnel salaries and benefits, managed care expenses and market research, advertising and promotional expenses related to Oracea, the Primus products and Pandel.

 

Selling expenses include personnel salaries and benefits, direct selling expenses and sales training expenses.

 

Corporate and administrative expenses include personnel salaries and benefits professional, legal and consulting fees, insurance, general office expenses, business development expenses and accounting expenses.

 

Selling, general and administrative expenses increased approximately $319,000, or 3.0%, during the three months ended September 30, 2007 as compared to the three months ended September 30, 2006, mainly due to an increase in managed care marketing and Oracea promotional costs. During the three months ended September 30, 2007, stock option expense decreased approximately $160,000, due primarily to performance-based awards amortized during the three months ended September 30, 2006. Such options were fully amortized at December 31, 2006.

 

We do not anticipate the termination during the fourth quarter of 2007 of our Sublicense Agreement with Altana Inc. and the termination of our License Agreement with Tolmar, Inc. to materially affect our selling and marketing expenses in the fourth quarter of 2007.

 

Interest Income (Expense)

 

Interest Income (Expense)

 

 

 

 

 

Change

 

(dollars in thousands)

 

2007

 

2006

 

$

 

%

 

Interest Income

 

$

772

 

$

409

 

$

363

 

88.8

%

Interest Expense

 

(8

)

(6

)

(2

)

33.3

%

Total Other Income (Expense)

 

$

764

 

$

403

 

$

361

 

89.6

%

 

Interest income increased $363,000 or 88.8%, primarily due to higher average investment balances and yields for the nine months ended September 30, 2007 compared to the comparable period in 2006.

 

Preferred Stock Dividend

 

Preferred stock dividends included in net loss allocable to common stockholders were $550,000 during the three months ended September 30, 2007 and $500,000 during the three months ended September 30, 2006.

 

Such preferred stock dividends are the result of our obligations in connection with the issuance of our Series D Cumulative Convertible Preferred Stock, or the Series D Stock, in May 1999. On December 15, 2005, we executed a

 

21



 

Restructuring and Exchange Agreement with each of the holders of our outstanding Series D Stock, pursuant to which, among other things, the Series D stockholders agreed to effect an exchange, whereby we exchanged all 200,000 outstanding shares of our Series D Stock for 200,000 shares of our Series D-1 Cumulative Convertible Preferred Stock, or the Series D-1 Stock.

 

Pursuant to the terms of our Series D-1 Stock, the holders of the Series D-1 Stock are entitled to dividends payable in cash at a current rate of 11.0% per annum, which are declared and paid every six months. The annual dividend rate increases by 1.0% on May 19, 2008 and each subsequent anniversary thereof until the earlier of the date that all of the shares of Series D-1 Stock are (i) converted into shares of common stock, or (ii) redeemed.

 

Comparison of the Nine Months Ended September 30, 2007 and September 30, 2006

 

Revenues

 

Revenues

 

 

 

 

 

Change

 

(dollars in thousands)

 

2007

 

2006

 

$

 

%

 

Net Oracea Product Sales

 

$

37,277

 

$

2,236

 

$

35,041

 

1,567.1

%

Other Net Product Sales

 

8,257

 

9,450

 

(1,193

)

(12.6

)%

Total Net Product Sales

 

45,534

 

11,686

 

33,848

 

289.6

%

Contract Revenues

 

734

 

1,040

 

(306

)

(29.4

)%

License Revenues

 

92

 

44

 

48

 

109.1

%

Grant Revenue

 

211

 

377

 

(166

)

(44.0

)%

Total Revenues

 

$

46,571

 

$

13,147

 

$

33,424

 

254.2

%

 

During the nine months ended September 30, 2007, total net product sales which included net sales of Oracea, Pandel, Periostat and the Atrix Products, increased $33.8 million, or 289.6%, due primarily to sales from Oracea, which was launched in July 2006. Net revenues from dermatological products were 90.7% of total net revenues in the nine months ended September 30, 2007 compared to 51.5% for the nine months ended September 30, 2006. Total deductions from gross sales for estimated product returns, trade cash discounts, managed care rebates, government and patient rebates and wholesale distribution fees for Oracea were approximately 14.2% of gross sales during the nine months ended September 30, 2007. Prescriptions for Oracea as reported by an independent industry data source were approximately 276,325 during the nine months ended September 30, 2007. At September 30, 2007, Oracea wholesaler inventory levels were approximately 4.1 weeks of sales as compared to approximately 1.0 weeks of sales at December 31, 2006

 

Effective November 1, 2007, our Sublicense Agreement with Altana Inc., a member of the Nycomed Group, will terminate and we will no longer generate other net product sales from the Pandel product. Effective November 14, 2007, our License Agreement with Tolmar, Inc. will terminate and we will no longer generate sales from the Atrix Products.

 

22



 

Cost of Product Sales

 

Cost of product sales for the nine months ended September 30, consist of the following:

 

Cost of Product Sales

 

 

 

 

 

Change

 

(dollars in thousands)

 

2007

 

2006

 

$

 

%

 

Manufacturing Costs

 

$

2,765

 

$

1,748

 

1,017

 

58.2

%

Product Royalties

 

3,790

 

1,362

 

2,428

 

178.3

%

Amortization of Licensing Fees

 

300

 

201

 

99

 

49.3

%

Cost of Product Sales

 

$

6,855

 

$

3,311

 

$

3,544

 

107.0

%

Percent of Net Product Sales

 

15.1

%

28.3

%

 

 

 

 

 

Manufacturing costs include contract manufacturing costs (Periostat and Oracea), transfer price (Pandel and the Atrix Products), manufacturing facility FDA validation costs, costs associated with excess inventories, overhead costs and internal costs.

 

Under our license agreement with SUNY, covering Periostat and Oracea, we are entitled to deduct prior legal costs incurred to defend SUNY’s patents from current and future royalties due SUNY on net sales of products based on SUNY technology. During the nine months ended September 30, 2007, we recorded $764 in product royalty expense and credited legal expense for $764 related to previously expensed legal fees. Accordingly, $764 was deducted from royalty payments earned by SUNY during the nine months ended September 30, 2007. During the nine months ended September 30, 2006, we recorded $335 in product royalty expense and credited legal expense for $335 related to previously expensed legal fees. Accordingly, $335 was deducted from royalty payments earned by SUNY during the nine months ended September 30, 2006. (see Note 9)

 

Cost of product sales increased $3.5 million during the nine months ended September 30, 2007 compared to the nine months ended September 30, 2006 due to increase in Oracea sales as well as approximately $180,000 in manufacturing facility FDA validation costs. Cost of product sales as a percent of net product sales was 15.1% for the nine months ended September 30, 2007 and 28.3% for the nine months ended September 30, 2006. The decrease in the cost of product sales as a percent of net product sales during the nine months ended September 30, 2007 as compared to the nine months ended September 30, 2006 is primarily due to the addition of Oracea sales, which have higher gross margins than our other products.

 

Effective November 1, 2007, our Sublicense Agreement with Altana Inc. will terminate and we will no longer generate other net product sales from the Pandel product. As part of the termination agreement, we expect to receive $1.7 million from Altana Inc. that will be credited to cost of product sales during the fourth quarter of 2007.

 

Research and Development

 

Research and development for the nine months ended September 30, consist of the following:

 

Research and Development

 

 

 

 

 

Change

 

(dollars in thousands)

 

2007

 

2006

 

$

 

%

 

incyclinide

 

$

5,037

 

$

5,218

 

$

(181

)

(3.5

)%

COL-118

 

3,710

 

494

 

3,216

 

651.0

%

Oracea

 

2,093

 

2,173

 

(80

)

(3.7

)%

becocalcidiol

 

1,712

 

 

1,712

 

N/A

 

Internal and Other Costs

 

3,612

 

2,702

 

910

 

33.7

%

Total Research and Development

 

$

16,164

 

$

10,587

 

$

5,577

 

52.7

%

 

23



 

Internal and other costs include personnel costs, stock option expense, regulatory compliance costs and other project development costs and other departmental costs.

 

Research and development expenses consist primarily of costs incurred for services and materials for drug development, manufacturing and formulation enhancements, clinical trials, purchased in-process research and development, statistical analysis and report writing and regulatory compliance costs (including drug approval submission and filing fees).

 

We estimate that future development and clinical costs associated with COL-118 will be approximately $18 to $22 million. It is premature to estimate future development and clinical costs for becocalcidiol. We are currently conducting formulation and stability work on products incorporating our Restoraderm technology, and we are reviewing product options and the timetable associated with clinical development or commercialization.

 

On September 26, 2007 and November 6, 2007, we announced that we had discontinued all development work on incyclinide for rosacea and acne indications, respectively.

 

During the fourth quarter of 2007 we expect to incur cancellation fees and other termination costs associated with the discontinuation of the incyclinide acne and rosacea development projects.

 

Selling, General and Administrative

 

Selling, general and administrative for the nine months ended September 30, consist of the following:

 

Selling, General and Administrative

 

 

 

 

 

Change

 

(dollars in thousands)

 

2007

 

2006

 

$

 

%

 

Marketing Expense

 

$

15,341

 

$

9,858

 

$

5,483

 

55.6

%

Selling Expense

 

12,127

 

11,350

 

777

 

6.8

%

Corporate & Administrative Expense

 

6,578

 

5,872

 

706

 

12.0

%

Stock Option Expense

 

1,657

 

2,211

 

(554

)

(25.1

)%

Total Selling, General and Administrative

 

$

35,703

 

$

29,291

 

$

6,412

 

21.9

%

 

Marketing expenses include personnel salaries and benefits, managed care expenses and market research, advertising and promotional expenses related to Oracea, the Primus products and Pandel.

 

Selling expenses include personnel salaries and benefits, direct selling expenses and sales training expenses.

 

Corporate and administrative expenses include personnel salaries and benefits professional, legal and consulting fees, insurance, general office expenses, business development expenses and accounting expenses.

 

Selling, general and administrative expenses increased approximately $6.4 million, or 21.9%, during the nine months ended September 30, 2007, mainly due to higher promotion costs for Oracea, which was launched in July 2006. During the nine months ended September 30, 2007, personnel costs related to selling, general and administrative functions increased by approximately $1.6 million as compared to personnel costs during the nine months ended September 30, 2006. During the nine months ended September 30, 2007, stock option expense decreased approximately $540,000 due primarily to amortization of performance-based awards amortized during the nine months ended September 30, 2006. Such options were fully amortized at December 31, 2006.

 

We do not anticipate the termination during the fourth quarter of 2007 of our Sublicense Agreement with Altana Inc. and the termination of our License Agreement with Tolmar, Inc. to materially affect our selling and marketing expenses in the fourth quarter of 2007.

 

24



 

Interest Income (Expense)

 

Interest Income (Expense)

 

 

 

 

 

Change

 

(dollars in thousands)

 

2007

 

2006

 

$

 

%

 

Interest Income

 

$

2,393

 

$

1,444

 

$

949

 

65.7

%

Interest Expense

 

(24

)

(6

)

(18

)

300.0

%

Total Other Income (Expense)

 

$

2,369

 

$

1,438

 

$

931

 

64.7

%

 

Interest income increased $949,000 or 65.7%, primarily due to higher average investment balances and yields for the nine months ended September 30, 2007 compared to the comparable period in 2006.

 

Preferred Stock Dividend

 

Preferred stock dividends included in net loss allocable to common stockholders were $1.6 million during the nine months ended September 30, 2007 and $1.4 million during the nine months ended September 30, 2006.

 

Such preferred stock dividends are the result of our obligations in connection with the issuance of our Series D Stock in May 1999.  On December 15, 2005, we executed a Restructuring and Exchange Agreement with each of the holders of our outstanding Series D Stock, pursuant to which, among other things, the Series D stockholders agreed to effect an exchange, whereby we exchanged all 200,000 outstanding shares of our Series D Stock for 200,000 shares of our Series D-1 Stock.

 

Pursuant to the terms of our Series D-1 Stock, the holders of the Series D-1 Stock are entitled to dividends payable in cash at a current rate of 11.0% per annum, which are declared and paid every six months.  The annual dividend rate increases by 1.0% on May 19, 2008 and each subsequent anniversary thereof until the earlier of the date that all of the shares of Series D-1 Stock are (i) converted into shares of common stock, or (ii) redeemed.

 

Liquidity and Capital Resources

 

Cash Requirements/Sources and Uses of Cash

 

We require cash to fund our operating expenses, capital expenditures and dividend payments on our outstanding Series D-1 Stock.  We have historically funded our cash requirements primarily through the following:

 

                  Public offerings and private placements of our preferred and common stock;

 

                  Cash flows from operations; and

 

                  Exercise of stock options and warrants.

 

We believe that other key factors that could affect our internal and external sources of cash are:

 

                  The cost of commercialization activities, including product marketing and sales;

 

                  The successful commercialization of Oracea and its acceptance by managed care organizations and other third party payors;

 

                  The success of our dermatology franchise;

 

                  The success of our prosecution of our patent applications related to the SansRosa technology and the use of COL-118 for the treatment of erythema;

 

                  Receipt and maintenance of marketing approvals from the FDA and similar foreign regulatory authorities for our product candidates;

 

25



 

                  The success of our preclinical, clinical and development programs;

 

                  Revenues and profits from sales of Oracea, and our other product candidates;

 

                  The terms and conditions of our outstanding Series D-1 Stock;

 

                  Our ability to continue to meet the covenant requirements under our amended revolving credit facility with Silicon Valley Bank, or SVB;

 

                  The costs involved in preparing, filing, prosecuting, maintaining and enforcing patent claims and other patent-related costs, including potential litigation costs and the results of such litigation;

 

                  The extent to which we acquire or invest in businesses, products and technologies;

 

                  The success of our application for European Union marketing authorization, for Oracea and in turn the success of MediGene AG, our foreign marketing partner for Oracea, in commercializing Oracea in the European Union;

 

                  The costs involved in obtaining and maintaining regulatory approvals and clearances required to market and sell our products; and

 

                  The receptivity of the capital markets to any future financings.

 

On May 15, 2007, we entered into the Sub-License Agreement with QuatRx to develop and commercialize becocalcidiol, a patented Vitamin D analogue developed by QuatRx that is currently in clinical development for the topical treatment of mild to moderate psoriasis.  The Sub-License Agreement provides us with an exclusive right, with the right to grant sublicenses, under various patents, patent applications and potential future patent applications to develop and sell products containing becocalcidiol, or the Products, for the topical treatment psoriasis and other skin diseases.  The license granted under the Sub-License Agreement is worldwide in coverage with the exception of Japan.  In exchange for the license, we paid QuatRx an upfront fee of $1.5 million and assumed all further costs of developing becocalcidiol for the topical treatment of skin diseases.  We have also agreed to pay QuatRx additional fees upon the achievement of certain development and sales milestones, including $1.5 million when the first patient enrolls in a Phase III trial, $2.0 million when an NDA for a product is accepted for review by the FDA and $3.0 million when an NDA is approved. Additional fees will be paid upon achievement of certain commercial milestones.   In addition, we agreed to make royalty payments to QuatRx based on annual future product sales during country-specific royalty terms, each extending until the later of (i) the expiration or invalidity of the last QuatRx-owned or licensed patent in the country covering the topical use of becocalcidiol to treat skin diseases, or (ii) ten years from the first commercial sale in the country of Products sold by us under the license.

 

On December 18, 2006, we executed a Product License and Supply Agreement with MediGene AG, a corporation existing under the laws of Germany, for the marketing rights to Oracea. Under the Product License and Supply Agreement, effective January 1, 2007, MediGene receives the right to manufacture, register, market and sell Oracea in the European Union, certain contiguous countries and Russia. MediGene may exercise its right to manufacture Oracea at any time during the term of the agreement, upon twelve months notice to us. During the nine months ended September 30, 2007, we received an upfront non-refundable fee of $5.0 million.  Additionally, we may be entitled to an additional $7.5 million in milestone payments upon the achievement of certain annual sales thresholds.  In addition, we will receive an agreed upon transfer price and a royalty of 12% of annual net sales up to $10 million and 15% of annual net sales in excess of $10 million in the specified territories. Our application for European marketing authorization for Oracea was recently referred to the Committee for Medicinal Products for Human Use, or CHMP. Referral to the CHMP may be a lengthy process and we cannot predict when, or if, this body will approve our application.

 

In November 2006, we raised $42.5 million in a public offering, net of placement agency fees and all related offering expenses.  In December 2005 and January 2006, we raised $15.5 million and $11.6 million, respectively, in a public offering, net of placement agency fees and all related offering expenses.

 

26



 

On October 9, 2006, we entered into a Sixth Loan Modification Agreement with SVB, or the Modification Agreement.  Pursuant to the terms of the Modification Agreement the expiration date of the credit facility has been extended to October 9, 2008.  Under the amended credit facility, we may borrow up to the lesser of (i) $10.0 million or (ii) 80% of eligible receivables plus certain specified amounts, subject to reduction during the period October 9, 2006 through December 31, 2007.  The amount available to us is reduced by any outstanding letters of credit that may be issued under the amended credit facility in amounts totaling up to $2.0 million. As we pay down amounts under any letter of credit, the amount available to us under the credit facility increases.  We are not obligated to draw down any amounts under the amended credit facility and any borrowings shall bear interest, payable monthly, at SVB’s prime rate, or 7.75%, at September 30, 2007. Under the Modification Agreement, we are charged an unused line credit fee of 0.25% per annum. In addition, under the amended credit facility, we are subject to financial covenants that require us to maintain certain minimum liquidity and tangible net worth levels on a quarterly basis.  During the nine months ended September 30, 2007 and 2006, our unused line of credit fee was $45,000 and $18,000 respectively. As of September 30, 2007, we had no borrowings outstanding.

 

At September 30, 2007, we had cash, cash equivalents and short-term investments of approximately $56.9 million compared to the approximately $65.8 million balance at December 31, 2006.  This decrease is primarily a result of cash used in investing activities of approximately $9.1 million during the nine months ended September 30, 2007.  In accordance with investment guidelines approved by our Board of Directors, cash balances in excess of those required to fund operations have been invested in government notes, commercial paper, certificates of deposit and money market funds.  Our working capital at September 30, 2007 was $58.5 million compared to $59.6 million at December 31, 2006.  During the nine months ended September 30, 2007, we invested $740,000 in capital expenditures and $2.2 million for in-process research and development, paid $2.0 million in cash dividends to the holders of our Series D-1 Stock and received proceeds of $2.5 million from the exercise of common stock options and warrants. During the nine months ended September 30, 2007 we also invested approximately $6.2 million in short-term investments (net of maturities).

 

We anticipate that our (i) current cash, cash equivalents and short-term investments at September 30, 2007, (ii) the availability of funds from our line of credit with SVB and (iii) our ability to control variable spending, will be sufficient to fund our operations through at least 2008. In addition, we may also finance our cash needs through public or private equity offerings, debt financings, corporate collaboration or licensing arrangements.  However, there is no assurance that these financing alternatives will be available on attractive terms, if at all, when needed, or in amounts sufficient to fund our operations.  Our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement that involves risks and uncertainties, and actual results could vary materially.

 

Cash Flows/Cash Management

 

Cash, cash equivalents and short-term investments at September 30, 2007 were $56.9 million representing 75% of total assets compared to $65.8 million, representing 83% of total assets at December 31, 2006.

 

The change in cash and cash equivalents for the nine months ended September 30, are as follows:

 

(dollars in millions)

 

2007

 

2006

 

Net cash used in operating activities

 

$

(6.4

)

$

(28.5

)

Net cash (used in) provided by investing activities

 

(9.1

)

0.3

 

Net cash provided by financing activities

 

0.4

 

11.5

 

Net decrease in cash and cash equivalents

 

$

(15.1

)

$

(16.7

)

 

Working capital at September 30, 2007 was $58.5 million compared to $59.6 million at December 31, 2006.

 

Net Cash Used in Operating Activities

 

Net cash used in operating activities was $6.4 million, including a $9.8 million net loss, and a $5.0 million payment from MediGene, during the nine months ended September 30, 2007 compared to $28.5 million, including a $28.6 million net loss for the nine months ended September 30, 2006.  Cash flows used in operations can vary significantly due to various

 

27



 

factors including the timing of payments made to our vendors, including research and development vendors, vendor payment terms, customer mix and customer payment terms. Our accounts receivable balance at September 30, 2007 increased compared to the balance at December 31, 2006 primarily as a result of increased Oracea sales.

 

Net Cash (Used In) Provided By Investing Activities

 

Net cash used in investing activities was $9.1 million for the nine months ended September 30, 2007, compared to $333,000 provided by investing activities for the nine months ended September 30, 2006.  The change is due primarily to $8.1 million in additional purchases of short-term investments (net of sales and maturities), a $2.0 million increase in purchases of in-process research and development and a $354,000 increase in capital expenditures during the nine months ended September 30, 2007.

 

Net Cash Provided By Financing Activities

 

Net cash provided by financing activities was approximately $415,000 for the nine months ended September 30, 2007, compared to net cash provided by financing activities of $11.5 million for the nine months ended September 30, 2006. The change is due primarily to proceeds from issuance of common stock that occurred in January 2006.

 

Contractual Obligations

 

Our major outstanding contractual obligations relate to cash dividends on our outstanding Series D-1 Stock, operating leases for our office space, and operating lease for commercial vehicles to be used by certain members of our sales force and capital leases for computer and telecommunications equipment. The disclosures relating to our contractual obligations in our Annual Report on Form 10-K for the year ended December 31, 2006 have not materially changed since we filed the report.

 

Critical Accounting Policies and Estimates

 

Management’s discussion and analysis of its financial position and results of operations are based upon our 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 management to make judgments and estimates that affect the reported amounts of assets, liabilities, revenues and expenses and related disclosure of contingent assets and liabilities.  Management believes the critical accounting policies and areas that require the most significant judgments and estimates to be used in the preparation of the consolidated financial statements pertain to revenue recognition, stock-based compensation and the valuation of deferred taxes, intangible assets and inventory.

 

Revenue Recognition

 

We generally recognize revenues for product sales upon shipment to wholesale customers, net of estimated returns and estimates for chargebacks, applicable wholesale distribution fees and rebates provided that collection was probable and no significant obligations remained. Following the launch of a third party generic competitor to Periostat in May 2005 and commencing with the second quarter of 2005, we began recognizing Periostat sales revenue based on product sales to end-users. As of September 30, 2007, we have a liability of $571,000 for potential Periostat product returns in accrued expenses on the Consolidated Balance Sheet for estimated returns prior to the change to a prescription based revenue recognition model.

 

We record sales discounts, allowances and returns upon recognizing product sales. We only accept unopened returns of damaged or expired products. The return allowance, when estimatable is based on an analysis of the historical returns of the product and similar products and we consider current end user demand and wholesale and retail inventory levels. If product returns are not estimatable, we defer revenue recognition for all outstanding products in the wholesale and retail channel that is subject to return. Pursuant to an agreement with one major customer, product returns are not permitted.  Chargebacks, wholesale distribution fees and rebates are based on an analysis of the applicable agreements and historical experience. In addition, we also consider the volume and price of the product in the channel, trends in wholesaler and retailer inventory levels, conditions that might affect end-user demand (such as generic competition) and other relevant factors.

 

The following chart details the activity in the revenue related reserves discussed above during the nine months ended September 30, 2007 and 2006:

 

28



 

Nine Months Ended September 30, 2006 
(dollars in thousands)

 

Balance 
December 31, 
2005

 

Current Provision 
Related to Sales 
During the Nine 
Months Ended 
September 30, 2006

 

Actual Returns or 
Credits Issued During 
the Nine Months 
Ended September 30, 
2006

 

Balance 
September 30, 
2006

 

Accounts receivable allowances:

 

 

 

 

 

 

 

 

 

Chargebacks

 

$

78

 

$

1,345

 

$

(1,369

)

$

54

 

Cash discounts

 

26

 

349

 

(227

)

148

 

Total

 

$

104

 

$

1,694

 

$

(1,596

)

$

202

 

 

 

 

 

 

 

 

 

 

 

Accounts payable/Accrued expenses:

 

 

 

 

 

 

 

 

 

Product returns (excluding Periostat)

 

98

 

293

 

(151

)