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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549


FORM 10-Q

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

For the quarterly period ended March 31, 2003

or

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:  000-23265


SALIX PHARMACEUTICALS, LTD.
(Exact name of Registrant as specified in its charter)

Delaware

 

94-3267443

(State or other jurisdiction of incorporation or organization)

 

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

8540 Colonnade Center Drive, Suite 501
Raleigh, North Carolina 27615

(Address of principal executive offices, including zip code)

(919) 862-1000
(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

               The number of shares of the Registrant’s Common Stock outstanding as of May 12, 2003 was 21,459,904.



Table of Contents

SALIX PHARMACEUTICALS, LTD.

TABLE OF CONTENTS

 

 

Page No.

 

 


 

 

 

PART I.

FINANCIAL INFORMATION

 

 

 

 

Item 1.

Condensed Consolidated Financial Statements

 

 

 

 

 

 

Condensed Consolidated Balance Sheets as of March 31, 2003(unaudited) and December 31, 2002 (audited)

1

 

 

Condensed Consolidated Statements of Operations for the Three Months Ended March 31, 2003 and 2002 (unaudited)

2

 

 

Condensed Consolidated Statements of Cash Flows for the Three Months Ended March 31, 2003 and 2002 (unaudited)

3

 

 

Notes to Condensed Consolidated Financial Statements

4

 

 

 

Item 2.

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

6

 

 

 

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

10

 

 

 

Item 4.

Controls and Procedures

10

 

 

 

PART II.

OTHER INFORMATION

 

 

 

 

Item 1.

Legal Proceedings

10

 

 

 

Item 6.

Exhibits and Reports on Form 8-K

11

 

 

 

Signatures

12

 

 

 

Certifications

13


Table of Contents

PART I.     FINANCIAL INFORMATION
Item 1.        Condensed Consolidated Financial Statements

SALIX PHARMACEUTICALS, LTD. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(U.S. dollars, in thousands, except share amounts)

 

 

March 31, 2003

 

December 31, 2002

 

 

 


 


 

 

 

(unaudited)

 

(audited)

 

ASSETS

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

28,576

 

$

34,531

 

Short-term investments

 

 

11,342

 

 

14,165

 

Accounts receivable, net

 

 

7,655

 

 

5,980

 

Inventory, net

 

 

9,424

 

 

10,210

 

Prepaid and other current assets

 

 

2,177

 

 

2,080

 

 

 



 



 

Total current assets

 

 

59,174

 

 

66,966

 

Long-term investments

 

 

7,042

 

 

7,052

 

Property and equipment, net

 

 

1,216

 

 

1,284

 

 

 



 



 

Total assets

 

$

67,432

 

 

75,302

 

 

 



 



 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

Accounts payable

 

$

1,577

 

$

3,029

 

Accrued liabilities

 

 

7,731

 

 

8,676

 

Deferred revenue

 

 

3,150

 

 

3,208

 

 

 



 



 

Total current liabilities

 

 

12,458

 

 

14,913

 

Commitments

 

 

—  

 

 

—  

 

Stockholders’ equity:

 

 

 

 

 

 

 

Preferred stock, $0.001 par value; 5,000,000 shares authorized, issuable in series, none outstanding

 

 

—  

 

 

—  

 

Common stock, $0.001 par value; 80,000,000 shares authorized, 21,375,846 shares issued and outstanding at March 31, 2003 and December 31, 2002, respectively.

 

 

21

 

 

21

 

Additional paid-in capital

 

 

131,298

 

 

131,300

 

Accumulated other comprehensive loss

 

 

(248

)

 

(306

)

Accumulated deficit

 

 

(76,097

)

 

(70,626

)

 

 



 



 

Total stockholders’ equity

 

 

54,974

 

 

60,389

 

 

 



 



 

Total liabilities and stockholders’ equity

 

$

67,432

 

$

75,302

 

 

 



 



 

The accompanying notes are an integral part of these financial statements.

1


Table of Contents

SALIX PHARMACEUTICALS, LTD.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
(U.S. dollars, in thousands, except per share data)

 

 

Three months ended
March 31,

 

 

 


 

 

 

2003

 

2002

 

 

 



 



 

Revenues:

 

 

 

 

 

 

 

Product revenue

 

$

11,522

 

$

6,211

 

 

 



 



 

Total revenues

 

 

11,522

 

 

6,211

 

Costs and expenses:

 

 

 

 

 

 

 

Cost of products sold

 

$

2,764

 

$

1,566

 

License fees and costs related to collaborative agreements

 

 

31

 

 

31

 

Research and development

 

 

5,150

 

 

2,485

 

Selling, general and administrative

 

 

9,619

 

 

6,978

 

 

 



 



 

Total cost and expenses

 

 

17,564

 

 

11,060

 

Loss from operations

 

 

(6,042

)

 

(4,849

)

Interest, and other income (expense), net

 

 

570

 

 

125

 

 

 



 



 

Net loss before tax

 

$

(5,472

)

$

(4,724

)

Income tax

 

 

—  

 

 

—  

 

 

 



 



 

Net loss

 

$

(5,472

)

$

(4,724

)

 

 



 



 

Net loss per share, basic and diluted

 

$

(0.26

)

$

(0.26

)

 

 



 



 

Shares used in computing net loss per share, basic and diluted

 

 

21,376

 

 

17,895

 

 

 



 



 

The accompanying notes are an integral part of these financial statements.

2


Table of Contents

SALIX PHARMACEUTICALS, LTD.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
(U.S. dollars, in thousands)

 

 

Three months ended
March 31,

 

 

 


 

 

 

2003

 

2002

 

 

 



 



 

Cash Flows From Operating Activities

 

 

 

 

 

 

 

Net loss

 

$

(5,472

)

$

(4,724

)

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

 

 

 

 

 

 

 

Depreciation and amortization

 

 

116

 

 

90

 

Changes in assets and liabilities:

 

 

 

 

 

 

 

Accounts receivable, inventory and other assets

 

 

(986

)

 

(886

)

Accounts payable and other current liabilities

 

 

(2,397

)

 

(599

)

Deferred revenue

 

 

(58

)

 

(50

)

 

 



 



 

Net cash used in operating activities

 

 

(8,797

)

 

(6,169

)

Cash Flows From Investing Activities

 

 

 

 

 

 

 

Purchases of property and equipment

 

 

(48

)

 

(154

)

Proceeds from maturity of investments

 

 

2,834

 

 

—  

 

 

 



 



 

Net cash provided by (used in) investing activities

 

 

2,786

 

 

(154

)

Cash Flows From Financing Activities

 

 

 

 

 

 

 

Proceeds from issuance of common stock

 

 

(2

)

 

57,595

 

 

 



 



 

Net cash (used in) provided by financing activities

 

 

(2

)

 

57,595

 

Effect of exchange rate changes on cash

 

 

58

 

 

—  

 

 

 



 



 

Net (decrease) increase in cash and cash equivalents

 

 

(5,955

)

 

51,272

 

Cash and cash equivalents at beginning of period

 

 

34,531

 

 

27,868

 

 

 



 



 

Cash and cash equivalents at end of period

 

$

28,576

 

$

79,140

 

 

 



 



 

The accompanying notes are an integral part of these financial statements.

3


Table of Contents

SALIX PHARMACEUTICALS, LTD.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

March 31, 2003
(Unaudited)

1.

Organization and Basis of Presentation

 

 

 

     Salix Pharmaceuticals, Ltd., (the “Company”) became a Delaware corporation on December 31, 2001 pursuant to a reorganization and continuation of the Company as a domestic entity.

 

 

 

     These statements are stated in United States dollars and are prepared under accounting principles generally accepted in the United States. The accompanying consolidated financial statements include the accounts of the Company and its subsidiaries. All significant intercompany balances and transactions have been eliminated.

 

 

 

     The accompanying unaudited condensed consolidated financial statements include all adjustments (consisting only of normal recurring items), which, in the opinion of management, are necessary for a fair presentation of financial position, results of operations and cash flows.  These financial statements should be read in conjunction with Management’s Discussion and Analysis of Financial Condition and Results of Operations included elsewhere in this Report and with the audited consolidated financial statements for the fiscal year ended December 31, 2002 included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2002 filed with the Securities and Exchange Commission.  The results of operations for interim periods are not necessarily indicative of results to be expected for a full year or any future period.

 

 

2.

Commitments

 

 

 

     At March 31, 2003, the Company had binding purchase order commitments for inventory purchases aggregating approximately $10.6 million over 10 months.

 

 

3.

Investments

 

 

 

     The Company considers all investments that have a maturity of greater than three months and less than one year to be short-term investments.  All securities with maturities beyond one year are considered long-term investments.  The Company’s short-term and long-term investments consist of government agency and high-grade corporate bonds.  The Company has the intent and ability to hold these investments until maturity; therefore, the investments are classified as held-to-maturity and are reported at amortized cost.

 

 

4.

Inventory

 

 

 

     Inventory at March 31, 2003 consisted of  $6.8 million of raw materials and $2.6 million of finished goods.  Inventory at December 31, 2002 consisted of $7.3 million of raw material and $2.9 million of finished goods.  As of March 31, 2003, the Company had approximately $2.2 million in raw material inventories relating to products that had not been approved by the U.S. Food and Drug Administration.

 

 

5.

Revenue Recognition

 

 

 

     In December 1999, the Securities and Exchange Commission issued Staff Accounting Bulletin No. 101, “Revenue Recognition in Financial Statements”, which among other guidance clarifies conditions to be met in order to recognize revenue.  SAB 101 requires companies to recognize certain up-front non-refundable fees over the term of the related agreement unless the fee is in exchange for products delivered or services performed that represent the culmination of a separate earnings process.

 

 

 

     Due to the uniqueness of each of its licensing arrangements, the Company analyzes each element of each contract, including milestone payments, to determine the appropriate revenue recognition.  In accordance with

4


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SAB 101, the Company recognizes revenue upon achievement of contractual milestones only when and to the extent the Company concludes that a separate earnings process has been culminated or the milestone is representative of the level of effort and progress toward completion of a long-term contract.

 

 

6.

Research and Development

 

 

 

     Research and development costs, both internal and externally contracted, are expensed as incurred.  These costs include direct expenditures for goods and services, as well as indirect expenditures such as salaries, administrative expenses and various allocated costs.

 

 

7.

Equity Offering

 

 

 

     On March 15, 2002, the Company completed a public offering of its common stock.  The Company raised approximately $57.4 million, net of offering costs, through the issuance of 4,600,000 shares of common stock.

 

 

8.

Recent Accounting Pronouncements

 

 

 

     In April 2002, the FASB issued SFAS No. 146, “Accounting for Costs Associated with Exit or Disposal Activities” (“SFAS 146”).  SFAS 146 addresses financial accounting and reporting for costs associated with exit or disposal activities and nullifies Emerging Issues Task Force (EITF) Issue No. 94-3, “Liability Recognition for Certain Employee Termination Benefits and Other Costs to Exit an Activity (including Certain Costs Incurred in a Restructuring) (“Issue 94-3”).  SFAS 146 addresses the accounting and reporting for costs associated with exit or disposal activities resulting from entities increasingly engaging in exit and disposal activities where certain costs associated with those activities were recognized as liabilities at a plan (commitment) date under Issue 94-3 but did not meet the definition of a liability in FASB Concepts Statement No. 6, “Elements of Financial Statements.” The standard became effective for us beginning January 1, 2003.  The adoption of SFAS 146 had no impact on our results of operations or financial position.

 

 

 

     In November 2002, the FASB issued FASB Interpretation No. 45, “Guarantor’s Accounting and Disclosure Requirements for Guarantees, Including Guarantees of Indebtedness of Others (an interpretation of FAS No. 5, 57 and 107 and rescission of FAS Interpretation No. 34)” (“FIN 45”), which modifies the accounting and enhances the disclosure of certain types of guarantees.  FIN 45 requires that upon issuance of certain guarantees, the guarantor must recognize a liability for the fair value of the obligation it assumes under the guarantee. The provisions of FIN 45 for the initial recognition and measurement are to be applied to guarantees issued or modified after December 31, 2002. The disclosure requirements are effective for financial statements of annual periods that end after December 15, 2002. The adoption of FIN 45 had no impact on our results of operations or financial position for the three months ending, nor as of, March 31, 2003.

 

 

9.

Comprehensive Loss

 

 

 

     Comprehensive loss is comprised of net loss and other comprehensive loss.  Other comprehensive loss includes certain changes in the shareholders’ equity of the Company that are excluded from net loss.  Specifically, other comprehensive loss includes foreign currency translation adjustments.

 

 

 

     Comprehensive loss for the three months ended March 31, 2003 and 2002 was as follows:


 

 

Three months ended March 31,

 

 

 


 

 

 

2003

 

2002

 

 

 



 



 

Net loss

 

$

(5,472

)

$

(4,724

)

Cumulative foreign currency translation adjustments

 

 

58

 

 

—  

 

 

 



 



 

Comprehensive loss

 

$

(5,414

)

$

(4,724

)

 

 



 



 

5


Table of Contents

10.     Stock-Based Compensation

          The Company accounts for stock-based awards to employees under the intrinsic value method in accordance with Accounting Principles Board Opinion No. 25, “Accounting for Stock Issued to Employees,” and has adopted the disclosure-only alternative of Statement of Financial Accounting Standards No. 123, “Accounting for Stock-Based Compensation”. Under APB 25, the Company generally recognizes no compensation expense with respect to such awards.

          In December 2002, the Financial Accounting Standards Board issued SFAS No. 148, “Account for Stock Based Compensation-Transition and Disclosure and amendment of FASB Statement No. 123”.  This statement amends FASB Statement No. 123 “Accounting for Stock Based Compensation”, to provide alternative methods of transition for a voluntary change to the fair value based method of accounting for stock based employee compensation.  In addition, this statement amends the disclosure requirements of Statement 123 to require prominent disclosures in both annual and interim financial statements about the method of accounting for stock based employee compensation and the effects of the method used on reported results (see below).  The standard is effective beginning with these financial statements and the provisions have been adopted herein. 

          Had compensation cost for the Company’s stock-based compensation plan been determined based on fair value at the grant dates for awards under those plans consistent with the method of SFAS No. 123, the Company’s net loss and loss per share would have been increased to the pro forma amounts indicated below for the periods ended March 31, 2003 and 2002, respectively.

 

 

March 31,

 

 

 


 

 

 

2003

 

2002

 

 

 



 



 

Net loss:

 

 

 

 

 

 

 

As reported

 

$

(5,472

)