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EX-99.1 - EX-99.1 - SALIX PHARMACEUTICALS LTDd859676dex991.htm

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of The Securities Exchange Act of 1934

Date of Report (Date of Earliest Event Reported): January 22, 2015

 

 

SALIX PHARMACEUTICALS, LTD.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   000-23265   94-3267443

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(I.R.S. Employer

Identification No.)

 

8510 Colonnade Center Drive

Raleigh, North Carolina

  27615
(Address of principal executive offices)   (Zip Code)

Registrant’s telephone number, including area code: (919) 862-1000

Not Applicable

(Former name or former address, if changed since last report)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 


Item 4.02. Non-Reliance on Previously Issued Financial Statements or a Related Audit Report or Completed Interim Review.

On January 22, 2015, the Audit Committee of the Board of Directors (the “Audit Committee”) of Salix Pharmaceuticals, Ltd. (the “Company”), after discussion with management and the Company’s independent registered public accounting firm, Ernst & Young LLP (“EY”), concluded that the Company’s previously issued audited consolidated financial statements for the year ended December 31, 2013 and the previously issued unaudited consolidated financial statements for the fiscal quarters ended March 31, June 30, and September 30, 2014, and the disclosures and related communications for each of those periods, require correction of certain errors and should no longer be relied upon. Management’s report on internal controls over financial reporting for the year ended December 31, 2013 should no longer be relied upon. Additionally, EY’s opinion on the consolidated financial statements for the year ended December 31, 2013, as well as EY’s opinion on the effectiveness of the Company’s internal controls over financial reporting as of December 31, 2013 should no longer be relied upon.

The impact of these errors, which are primarily associated with the timing for recognition of certain revenue, revenue-reducing returns and discounts, and expenses, on previously reported net income or loss after income taxes for each of these periods is estimated to be as follows:

 

Period

   Effect    Amount (millions)  

Year ended December 31, 2013

   Reduction in net income    $ 11.8   

Quarter ended March 31, 2014

   Reduction in net loss    $ 8.9   

Quarter ended June 30, 2014

   Reduction in net income    $ 3.4   

Quarter ended September 30, 2014

   Increase in net loss    $ 5.5   

The Company anticipates that it will file its Annual Report on Form 10-K for the fiscal year ended December 31, 2014 (the “2014 10-K”) on a timely basis on or before March 2, 2015. Immediately prior to filing the 2014 10-K, the Company will restate the financial results contained in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2013 and the previously unaudited financial statements and other financial information contained in the Company’s Quarterly Reports on Form 10-Q for the fiscal quarters ended March 31, June 30, and September 30, 2014, and the disclosures and related communications for these periods (collectively the “Prior Financial Information”). The Audit Committee and the Company presently do not expect to identify any material adjustments in the restated financial statements other than those discussed below.

As previously disclosed, the Audit Committee has been conducting a review of prior public disclosures of inventory amounts in the distribution channel and related issues in press releases, on analyst calls, and in the Company’s various SEC filings. Outside counsel, reporting to the Audit Committee, has engaged BDO Consulting, a division of BDO USA, LLP (“BDO”), to assist in the review of accounting and financial reporting issues associated with sales to wholesalers and other wholesaler-related transactions. The Audit Committee’s review also prompted the Company to reevaluate its classification of certain expenses, which has resulted in the estimated changes identified below to certain classifications.


The following are errors that the Audit Committee and the Company recently identified that will be corrected through the restatements.

 

    The Company incorrectly recognized only an $8.7 million reserve for product returns at December 31, 2013 for certain out-of-policy returns of GIAZO® when it should have recognized a reserve of approximately $16.9 million, as the Company had agreed to accept such returns in the fourth quarter of 2013. This correction will result in approximately $8.2 million of reduced net revenue in 2013 and a corresponding increase of approximately $8.2 million in net revenue for the first quarter of 2014 as the returns were originally recorded in the first quarter of 2014.

 

    The Company recognized revenue for certain shipments to a wholesale customer with FOB Destination shipping terms, as set forth in a contract entered between the Company and the wholesale customer during the quarter ended December 31, 2013, that were not received by the customer by the close of the fiscal periods. Of those shipments that were delivered to the wholesaler after the end of the fiscal period, nearly all were shipped four or more days prior to the end of the fiscal period but arrived at the wholesaler a few days into the next fiscal period. This category of errors impacts the fourth quarter and year ended December 2013, and the first three quarters of 2014 as follows:

 

    The Company incorrectly recognized revenue of approximately $14.4 million in the fiscal quarter ended December 31, 2013 that should have been recognized in the fiscal quarter ended March 31, 2014, based upon delivery in early January 2014.

 

    The Company incorrectly recognized revenue of approximately $1 million in the fiscal quarter ended March 31, 2014 that should have been recognized in the fiscal quarter ended June 30, 2014, based upon delivery in early April 2014, and did not recognize the approximately $14.4 million of revenue discussed above.

 

    The Company did not recognize the approximately $1 million of revenue discussed above in the fiscal quarter ended June 30, 2014. There was an inconsequential amount of revenue recognized in the fiscal quarter ended June 30, 2014 associated with shipments that were not delivered until early July 2014.

 

    The Company incorrectly recognized revenue of approximately $15.2 million in the fiscal quarter ended September 30, 2014 that should have been recognized in the fiscal quarter ended December 31, 2014, based upon delivery in early October 2014.


    The Company incorrectly accounted for expenditures associated with a sale to a wholesaler in the fiscal quarter ended March 31, 2014. In connection with the sale transaction, the Company agreed to pay the wholesaler $0.5 million for marketing services and the Company recognized this payment as an expense in the fiscal quarter ended June 30, 2014. At the wholesaler’s request, the Company agreed to an additional $0.5 million credit to the wholesaler for this transaction to consummate an additional sale in the fiscal quarter ended June 30, 2014 that was recorded as an expense in the fiscal quarter ended September 30, 2014. The Company should have accounted for the first $0.5 million payment as a revenue reducing discount in the fiscal quarter ended March 31, 2014 rather than as an operating expense in the fiscal quarter ended June 30, 2014, and the second $0.5 million credit as a revenue reducing discount in the fiscal quarter ended June 30, 2014 rather than as an operating expense in the fiscal quarter ended September 30, 2014.

 

    The Company also incorrectly accounted for additional expenditures associated with another sale to the same wholesaler discussed immediately above in the fiscal quarter ended June 30, 2014. In connection with the sales transaction, the Company agreed to pay the wholesaler approximately $7.5 million for marketing services over twelve months beginning in July 2014, and the Company recognized expenses of approximately $1.9 million under this agreement in the fiscal quarter ended September 30, 2014. The Company should have accounted for the entire approximately $7.5 million as a revenue reducing discount in the fiscal quarter ended June 30, 2014 rather than as an operating expense as the cash was paid in the fiscal quarter ended September 30, 2014 and future periods.

 

    In the Consolidated Balance Sheet as of September 30, 2014, $1.9 million was classified as raw material inventory that should have been expensed as Research & Development (“R&D”) in the fiscal quarter ended December 31, 2013 and the fiscal quarters ended March 31, June 30 and September 30, 2014. This error relates to raw material inventory that should not have been capitalized based on a change in the stage of development of the product. The increase in R&D Expense on the fiscal quarter ended December 31, 2013 is approximately $1.1 million and on the first three quarters of 2014 is approximately $265,000 in each quarter.

 

   

The Company incorrectly classified certain expenses as related to R&D instead of Selling, General, and Administrative (“SG&A”) expenses. These errors largely were a result of the Company’s historical practice of aligning certain expenses along organizational hierarchy, rather than the business activity. The Company incorrectly recorded expenses of approximately $32.5 million, $38.3 million, and $38.2 million as R&D rather than SG&A for the fiscal years ended December 31, 2011, December 31, 2012, and December 31, 2013, respectively. The Company incorrectly recorded expenses of approximately $11.8 million, $13.3 million, and $12.0 million as related to R&D rather than SG&A for the fiscal quarters ended March 31, 2014, June 30, 2014, and September 30, 2014, respectively. The corresponding corrections for the fiscal quarters in 2013 would be a reduction in R&D and an increase of SG&A of $8.7 million for the fiscal quarter ended


 

March 31, 2013, $10.1 million for the fiscal quarter ended June 30, 2013, $9.0 million for the fiscal quarter ended September 30, 2013, and $10.4 million for the fiscal quarter ended December 31, 2013. These changes do not impact revenue or net income or loss.

The following are immaterial errors that were previously identified which now will be corrected as part of the restatement of the errors above:

 

    In the Consolidated Statement of Cash Flows for the three months ended March 31, 2014, an approximately $27 million change in acquisition-related contingent consideration was improperly classified within cash flows from operating activities that should have been classified as cash flows from investing activities. This change does not impact revenue or income, and increases cash flows used in investing activities. This item was reflected appropriately in the June 30, 2014 Consolidated Statement of Cash Flows as filed.

 

    In the Consolidated Balance Sheet as of March 31, 2014, $60 million of a senior secured term loan was improperly classified as long-term that should have been classified as a current liability. This change does not impact revenue or income.

 

    In the Consolidated Balance Sheet as of June 30, 2014, an approximately $4.7 million receivable was incorrectly included as a reduction in liabilities and should have been recorded as a receivable and included in prepaid expenses and other current assets. This change does not impact revenue or income.

 

    During the fiscal quarter ended September 30, 2014, the Company incorrectly reduced its inventory reserve by approximately $2.7 million, which was reflected in the Consolidated Balance Sheet and Consolidated Statement of Comprehensive Income.

 

    In the Consolidated Balance Sheet as of September 30, 2014, the Company incorrectly included a $1.3 million credit balance in other current assets that should have been reclassified to reduce goodwill. This change does not impact revenue or income.


The Company is working with the Audit Committee and the Audit Committee’s advisors to determine the final adjustments required to be made to the Prior Financial Information as expeditiously as possible. Based on the information presently available, the Company expects the following restated financial results:

Summary of Expected Adjustments for the Restatement of the Consolidated Financial Statements of Salix Pharmaceuticals, Ltd.

 

    

As Previously

Reported

    Adjustments    

As

Revised

   

%

Change

 
  

 

 

   
     (in thousands, except per share data)        

Twelve months ended December 31, 2013

        

Effected Consolidated Statement of Comprehensive Income (Loss) Accounts

        

Net product revenues

   $ 933,838      $ (20,056   $ 913,782        -2.1

Cost of products sold

     179,392       (1,616     177,776       -0.9

Research and development

     149,974       (37,183     112,791       -24.8

Selling, general and administrative

     304,215       38,145       342,360       12.5

Total costs and expenses

     662,125       (654     661,471       -0.1

Income from operations

     271,713       (19,402     252,311       -7.1

Income tax expense

     69,031       (7,554     61,477       -10.9

Net income

     143,034       (11,848     131,186       -8.3

Net income per share - diluted

   $ 2.18      $ (0.18   $ 2.00        -8.3

Effected Consolidated Balance Sheet Accounts

        

Accounts receivable, net

   $ 147,933       (22,531     125,402       -15.2

Inventory

     104,395       (186     104,209       -0.2

Deferred tax assets

     86,693       (905     85,788       -1.0

Accrued liabilities

     97,661       (1,127     96,534       -1.2

Reserve for product returns, rebates and chargebacks

     246,838       (2,187     244,651       -0.9

Income taxes payable

     43,354       (8,534     34,820       -19.7

Deferred tax liabilities - long-term

     42,371       75       42,446       0.2

Retained earnings

     71,654       (11,848     59,806       -16.5

Three months ended March 31, 2014

        

Effected Consolidated Statement of Comprehensive Income (Loss) Accounts

        

Net product revenues

   $ 384,374      $ 18,604      $ 402,978        4.8

Cost of products sold

     115,566       1,374       116,940       1.2

Research and development

     52,758       (11,536     41,222       -21.9

Selling, general and administrative

     195,205       11,892       207,097       6.1

Total costs and expenses

     422,463       1,730       424,193       0.4

Income (loss) from operations

     (38,089     16,874       (21,215     -44.3

Income tax benefit (expense)

     36,368       (7,973     28,395       -21.9

Net income (loss)

     (43,872     8,901       (34,971     -20.3

Net income (loss) per share - diluted

   $ (0.69   $ 0.14      $ (0.55     -20.4

Effected Consolidated Balance Sheet Accounts

        

Accounts receivable, net

   $ 438,545        (1,597     436,948        -0.4

Inventory

     147,072       (1,297     145,775       -0.9

Prepaid and other current assets

     110,993       (8,121     102,872       -7.3

Accrued liabilities

     170,453       (241     170,212       -0.1

Reserve for product returns, rebates and chargebacks

     307,749       (126     307,623       0.0

Current portion of senior term loan

     —         60,000       60,000       N/A   

Senior term loan - long-term

     1,185,000       (60,000     1,125,000       -5.1

Additional paid-in capital

     681,954       (148     681,806       0.0

Retained earnings

     27,782       (2,947     24,835       -10.6

Three months ended June 30, 2014

        

Effected Consolidated Statement of Comprehensive Income (Loss) Accounts

        

Net product revenues

   $ 382,000      $ (6,463   $ 375,537        -1.7

Cost of products sold

     104,325       242       104,567       0.2

Research and development

     39,231       (13,506     25,725       -34.4

Selling, general and administrative

     124,937       13,276       138,213       10.6

Total costs and expenses

     333,550       12       333,562       0.0

Income from operations

     48,450       (6,475     41,975       -13.4

Income tax expense (benefit)

     2,707       (3,082     (375     -113.9

Net income

     3,278       (3,393     (115     -103.5

Net income per share - diluted

   $ 0.04      $ (0.04   $ (0.00     -100.0

Effected Consolidated Balance Sheet Accounts

        

Accounts receivable, net

   $  481,488       581        482,069       0.1

Inventory

   $ 144,431       (1,588     142,843       -1.1

Prepaid and other current assets

     126,885       7,068       133,953       5.6

Accounts payable

     33,676       4,658        38,334        13.8

Accrued liabilities

     202,872        7,995        210,867        3.9

Additional paid-in capital

     703,591       (672     702,919       -0.1

Retained earnings

     31,060       (6,340     24,720       -20.4

Three months ended September 30, 2014

        

Effected Consolidated Statement of Comprehensive Income (Loss) Accounts

        

Net product revenues

   $ 354,719      $ (12,826   $ 341,893        -3.6

Cost of products sold

     86,298       (188     86,110       -0.2

Research and development

     50,837       (14,159     36,678       -27.9

Selling, general and administrative

     165,622       11,960       177,582       7.2

Total costs and expenses

     434,346       (2,387     431,959       -0.5

Income (loss) from operations

     (79,627 )     (10,439     (90,066     13.1

Income tax (expense) benefit

     36,392       4,905       41,297       13.5

Net income (loss)

     (88,595 )     (5,534     (94,129     6.2

Net income (loss) per share - diluted

   $ (1.39   $ (0.09   $ (1.48     6.3

Effected Consolidated Balance Sheet Accounts

        

Accounts receivable, net

   $ 522,632       (15,204     507,428       -2.9

Inventory

     155,150       (4,057     151,093       -2.6

Prepaid and other current assets

     168,053       7,067       175,120       4.2

Goodwill

     1,310,060       (1,343     1,308,717       -0.1

Accrued liabilities

     220,642       2,834        223,476        1.3

Reserve for product returns, rebates and chargebacks

     316,293       (2,072     314,221       -0.7

Additional paid-in capital

     585,701       819       586,520       0.1

Retained earnings (accumulated deficit)

     (57,535 )     (11,874     (69,409     20.6 %


In light of the Audit Committee’s review, the Company and the Audit Committee are reevaluating the Company’s internal control over financial reporting and its disclosure controls and procedures. Management, in consultation with the Audit Committee, also has determined that material weaknesses existed in the Company’s internal control over financial reporting and that disclosure controls and procedures were ineffective at December 31, 2013 and through December 31, 2014. In consultation with the Audit Committee and its counsel, the Company intends to enhance its procedures and controls based on information identified during the Audit Committee’s review and the restatement process.

The Audit Committee and the Company’s management have discussed the matters disclosed in this Item 4.02 with Ernst & Young LLP.

Item 7.01. Regulation FD Disclosure.

On January 28, 2015, the Company issued a press release regarding the matters discussed in Item 4.02 above. A copy of the press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.

The information in this Item 7.01, including the related press release, is being furnished pursuant to Item 7.01 of Form 8-K and General Instruction B.2 thereunder, and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section. This information shall not be deemed to be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any general incorporation language in such filing. This information will not be deemed an admission as to the materiality of such information that is being disclosed solely pursuant to Regulation FD.

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit

  

Description

99.1    Press Release issued by the Company on January 28, 2015.


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

Date: January 28, 2015 SALIX PHARMACEUTICALS, LTD.
By:

/s/ WILLIAM BERTRAND, JR.

William Bertrand, Jr.
Senior Vice President and General Counsel


Exhibit Index

 

Exhibit

  

Description

99.1    Press Release issued by Salix Pharmaceuticals, Ltd. on January 28, 2015.