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EX-99.1 - AUDITED CONSOLIDATED FINANCIAL STATEMENTS - SALIX PHARMACEUTICALS LTDd306326dex991.htm
EX-23.1 - CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM - SALIX PHARMACEUTICALS LTDd306326dex231.htm

EXHIBIT 99.2

CONSOLIDATED FINANCIAL STATEMENTS

Oceana Therapeutics, Inc.

For the Quarterly Period Ended September 30, 2011


Oceana Therapeutics, Inc.

Unaudited Consolidated Financial Statements

Nine Months Ended September 30, 2011

Contents

 

Consolidated Balance Sheets as of September 30, 2011 (Unaudited) and December 31, 2010 (Audited)

     1   

Consolidated Statements of Operations for the Nine Months Ended September 30, 2011 and 2010 (Unaudited)

     2   

Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2011 and 2010 (Unaudited)

     3   

Notes to Unaudited Consolidated Financial Statements

     4   


Oceana Therapeutics, Inc.

Unaudited Consolidated Balance Sheets

 

     September 30,
2011
    December 31,
2010
 
     (Unaudited)        

Assets

    

Current assets:

    

Cash and cash equivalents

   $ 15,519,764      $ 7,304,742   

Restricted cash

     400,000        475,000   

Accounts receivable, net of reserves

     5,009,900        4,996,785   

Inventory

     2,195,602        1,911,809   

Prepaid expenses and other current assets

     575,448        667,855   
  

 

 

   

 

 

 

Total current assets

     23,700,714        15,356,191   

Property and equipment, net

     443,777        453,601   

Restricted cash

     100,000        100,000   

Intangible assets

     51,827,067        59,762,817   

Others assets

     57,435        47,987   
  

 

 

   

 

 

 

Total assets

   $ 76,128,993      $ 75,720,596   
  

 

 

   

 

 

 

Liabilities and stockholders’ equity

    

Current liabilities:

    

Accounts payable and accrued expenses

   $ 5,768,961      $ 6,334,452   

Other current liabilities

     90,261        68,631   
  

 

 

   

 

 

 

Total current liabilities

     5,859,222        6,403,083   

Other liabilities

     149,438        211,508   

Deferred taxes

     —          1,127,351   

Contingent liability from acquisition

     6,165,425        16,087,250   
  

 

 

   

 

 

 

Total liabilities

     12,174,085        23,829,192   

Commitments and contingencies

    

Stockholders’ equity:

    

Common stock; $0.0001 par value; 100 shares authorized, issued and outstanding at September 30, 2011 and December 31, 2010

     —          —     

Additional paid-in capital

     102,250,000        77,250,000   

Other comprehensive loss

     (201,716     (157,895

Accumulated deficit

     (38,093,376     (25,200,701
  

 

 

   

 

 

 

Total stockholders’ equity

     63,954,908        51,891,404   
  

 

 

   

 

 

 

Total liabilities and stockholders’ equity

   $ 76,128,993      $ 75,720,596   
  

 

 

   

 

 

 

See accompanying notes to unaudited consolidated financial statements.

 

1


Oceana Therapeutics, Inc.

Consolidated Statements of Operations (Unaudited)

 

    

Nine Months Ended

September 30

 
     2011     2010  

Net revenue

   $ 25,951,992      $ 23,092,598   

Cost of goods sold

     17,076,183        13,491,349   
  

 

 

   

 

 

 

Gross profit

     8,875,809        9,601,249   

Expenses:

    

Selling, general and administrative expenses

     16,369,569        13,249,629   

Research and development expenses

     1,518,196        2,616,543   

Net change in contingent consideration

     5,078,175        1,205,438   
  

 

 

   

 

 

 

Loss from operations

     (14,090,131     (7,470,361

Interest income

     5,321        7,771   

Other income (expense)

     64,785        (185,355
  

 

 

   

 

 

 

Loss before income tax

     (14,020,025     (7,647,945

Benefit (provision) for income taxes

     1,127,350        (198,640
  

 

 

   

 

 

 

Net loss

   $ (12,892,675   $ (7,846,585
  

 

 

   

 

 

 

See accompanying notes to unaudited consolidated financial statements.

 

2


Oceana Therapeutics, Inc.

Consolidated Statements of Cash Flows (Unaudited)

 

    

Nine Months Ended

September 30

 
     2011     2010  

Operating activities

    

Net loss

   $ (12,892,675   $ (7,846,585

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

    

Depreciation and amortization

     8,076,064        7,038,484   

Deferred taxes

     (1,127,351     198,640   

Changes in operating assets and liabilities:

    

Accounts receivable

     (14,260     (1,677,104

Inventory

     (283,879     (81,481

Security deposit

     65,552        401,751   

Prepaid expenses and other current assets

     (13,617     (447,680

Accounts payable and accrued expenses

     (155,384     99,217   

Contingent consideration

     (439,275     1,205,438   

Deferred rent

     16,048        (7,973
  

 

 

   

 

 

 

Net cash used in operating activities

     (6,768,777     (1,117,293

Investing activities

    

Additions to property and equipment

     (152,623     (19,502
  

 

 

   

 

 

 

Net cash used in investing activities

     (152,623     (19,502

Financing activities

    

Capital contribution from stockholders

     25,000,000        —     

Solesta® milestone payment

     (9,482,550     —     
  

 

 

   

 

 

 

Net cash provided by financing activities

     15,517,450        —     
  

 

 

   

 

 

 

Effect of exchange rate changes on cash and cash equivalents

     (381,028     202,948   
  

 

 

   

 

 

 

Net increase (decrease) in cash and cash equivalents

     8,215,022        (933,847

Cash and cash equivalents at beginning of period

     7,304,742        8,738,750   
  

 

 

   

 

 

 

Cash and cash equivalents at end of period

   $ 15,519,764      $ 7,804,903   
  

 

 

   

 

 

 

See accompanying notes to unaudited consolidated financial statements.

 

3


Oceana Therapeutics, Inc.

Notes to Unaudited Consolidated Financial Statements

September 30, 2011

1. Description of Business and Significant Accounting Policies

Organization

Oceana Therapeutics, Inc. (the “Company”) is a privately owned, global healthcare company committed to commercializing best-in-class therapeutics with a focus on colorectal, gastroenterology and urological diseases. The Company’s activities have consisted of the marketing and sales of two medical device products.

Basis of Presentation

The accompanying unaudited consolidated financial statements have been prepared in accordance with United States generally accepted accounting principles (“U.S. GAAP”) and with the instructions to Article 10 of Regulation S-X. Accordingly, they do not include all information and footnotes required by U.S. GAAP for complete financial statements. In the opinion of management, the accompanying consolidated financial statements include all adjustments (including normal recurring accruals) considered necessary for fair presentation of the Company’s consolidated financial position, results of operations and cash flows for the periods presented. Operating results for the current interim period are not necessarily indicative of the results that may be expected for the year ended December 31, 2011. These financial statements should be read in conjunction with the audited financial statements and accompanying notes for the year ended December 31, 2010.

The unaudited consolidated financial statements include the accounts of Oceana Therapeutics, Inc. and its wholly owned subsidiary, Oceana Therapeutics Limited. Intercompany transactions and balances are eliminated in consolidation.

Use of Estimates

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

Cash and Cash Equivalents

The Company considers all investments purchased with a maturity of three months or less at the date of acquisition to be cash equivalents.

 

4


Oceana Therapeutics, Inc.

Notes to Unaudited Consolidated Financial Statements (continued)

1. Description of Business and Significant Accounting Policies (continued)

 

Restricted Cash

Restricted cash collateralizes outstanding letters of credit associated with a lease for office space in Edison, New Jersey. The funds are invested in certificates of deposit. The letter of credit permits draws by the landlord to cure defaults by the Company. Additionally, the restricted cash is collateralized with a certificate of deposit, in the event the Company defaults in its obligations under foreign exchange contracts with a financial institution.

Income Taxes

The Company uses the asset and liability method to account for income taxes, including the recognition of deferred tax assets and deferred tax liabilities for the anticipated future tax consequences attributable to differences between financial statement amounts and their respective tax bases. The Company reviews its deferred tax assets for recovery. A valuation allowance is established when the Company believes that it is more likely than not that its deferred tax assets will not be realized. Changes in valuation allowances from period to period are included in the Company’s tax provision in the period of change. The nine-month period ended September 30, 2011 includes the tax effect of netting the deferred tax liabilities with deferred tax assets. Prior to the approval of Solesta® in the United States, the Company was not able to predict the timing of the reversal of this temporary difference. The net impact of this change in estimate was a realization of deferred tax assets of approximately $1.1 million.

Comprehensive Income (Loss)

Comprehensive income (loss) is comprised of net income (loss) and other comprehensive income (loss). Other comprehensive income (loss) includes changes in the fair value of the Company’s cash flow hedges and foreign exchange translation adjustments. The following table sets forth the components of comprehensive income (loss):

 

     Nine Months Ended
September 30
 
     2011     2010  

Net loss

   $ (12,892,675   $ (7,846,585

Change in fair value of cash flow hedges

     (26,583     289,376   

Unrealized loss on foreign exchange

     (17,238     (145,907
  

 

 

   

 

 

 

Total comprehensive loss

   $ (12,936,496   $ (7,703,116
  

 

 

   

 

 

 

 

5


Oceana Therapeutics, Inc.

Notes to Unaudited Consolidated Financial Statements (continued)

 

2. Foreign Exchange Forward Contracts

The Company, in the normal course of business, periodically enters into foreign exchange forward contracts to reduce the risk associated with currency movements (primarily between the U.S. Dollar, the Euro and Swedish Krona) related to committed inventory purchases denominated in foreign currency. The Company does not enter into these contracts for the purpose of trading or speculation. The fair value of foreign currency contract derivatives is based on quoted prices for similar assets or liabilities in active markets adjusted for nonperformance risk.

The Company designates its forward foreign currency contracts as effective cash flow hedges. In order to qualify as effective cash flow hedges, the Company’s forward foreign currency contracts must satisfy various criteria. Those criteria include documenting, at inception, the hedging relationship and the risk management objective and strategy for undertaking the hedge. This documentation includes identifying the hedged instrument, the hedged transaction, the nature of the risk being hedged, and how the hedging instrument’s effectiveness in hedging the exposure to the hedged transaction’s variability in cash flows attributable to the hedged risk will be assessed. In addition, the forecasted transactions that are being hedged are specifically identifiable and the occurrence of the forecasted transactions is probable. The critical terms of the Company’s foreign currency contracts are the same as the underlying forecasted transactions; therefore, changes in the fair value of the contracts should be highly effective in offsetting changes in the expected cash flows from the forecasted transactions. Accordingly, changes in the fair value of forward exchange contracts are recorded in other comprehensive income (loss), net of related tax effects, with the corresponding asset or liability recorded in the consolidated balance sheets.

The valuation of the Company’s derivative financial instruments is based on similar instruments quoted in the open market.

For all hedging activities, the ineffective portion of a derivative’s change in fair value is immediately recognized in other income (expense). For derivative instruments not designated as hedging instruments, the gain or loss is recognized in other income (expense) during the period of change. The Company believes that any such non-designated instruments would offset the economic risks of the hedged items. Ineffectiveness of the hedged items is not significant.

 

6


Oceana Therapeutics, Inc.

Notes to Unaudited Consolidated Financial Statements (continued)

2. Foreign Exchange Forward Contracts (continued)

 

At September 30, 2011, the notional amounts and estimated fair values, using quotes from external sources (Level 2), of the Company’s outstanding forward foreign currency contracts are detailed below:

 

     September 30,
2011
     December 31,
2010
 

Foreign Currency

   Fair Value
Asset
(Liability)
    Notional
Amount
     Fair Value
Asset
     Notional
Amount
 

Euro

   $ 1,338      $ 472,536       $ 50,037       $ 587,489   

Swedish Krona

   $ (27,921   $ 632,565       $ 13,593       $ 1,080,840   

Cost of sales includes a loss of $30,259 for the period ended September 30, 2011 and a gain of $23,936 for the period ended September 30, 2010, related to the settlement of foreign denominated inventory purchases.

The following tables set forth the Company’s financial assets and liabilities that were measured at fair value on a recurring basis at September 30, 2011 by level within the fair value hierarchy. As required by ASC 820, Fair Value Measurements and Disclosures, assets and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires judgment and considers factors specific to the asset or liability.

 

     September 30, 2011  
     Quoted Prices
in Active
Markets for

Identical Assets
(Level 1)
     Significant
Other
Observable
Inputs

(Level 2)
     Significant
Unobservable

Inputs
(Level 3)
     Total  

Assets and liabilities

           

Assets:

           

Money market

   $ 3,013,674       $ —         $ —         $ 3,013,674   
  

 

 

    

 

 

    

 

 

    

 

 

 

Total assets at fair value

   $ 3,013,674       $ —         $ —         $ 3,013,674   
  

 

 

    

 

 

    

 

 

    

 

 

 

Liabilities:

           

Foreign exchange forward contract

   $ —         $ 26,582       $ —         $ 26,582   

Contingent purchase price

     —           —           6,165,425         6,165,425   
  

 

 

    

 

 

    

 

 

    

 

 

 

Total liabilities at fair value

   $ —         $ 26,582       $ 6,165,425       $ 6,192,007   
  

 

 

    

 

 

    

 

 

    

 

 

 

 

7


Oceana Therapeutics, Inc.

Notes to Unaudited Consolidated Financial Statements (continued)

2. Foreign Exchange Forward Contracts (continued)

 

     December 31, 2010  
     Quoted Prices
in Active
Markets for

Identical Assets
(Level 1)
     Significant
Other
Observable
Inputs

(Level 2)
     Significant
Unobservable

Inputs
(Level 3)
     Total  

Assets and liabilities

           

Assets:

           

Money market

   $ 3,010,980       $ —         $ —         $ 3,010,980   

Foreign exchange forward contract

     —           63,630         —           63,630   
  

 

 

    

 

 

    

 

 

    

 

 

 

Total assets at fair value

   $ 3,010,980       $ 63,630       $ —         $ 3,074,610   
  

 

 

    

 

 

    

 

 

    

 

 

 

Liabilities:

           

Contingent purchase price

   $ —         $ —         $ 16,087,250       $ 16,087,250   
  

 

 

    

 

 

    

 

 

    

 

 

 

Total liabilities at fair value

   $ —         $ —         $ 16,087,250       $ 16,087,250   
  

 

 

    

 

 

    

 

 

    

 

 

 

There has been a change in fair value of the Company’s Level 3 contingent purchase price during the period ended September 30, 2011.

The following is a reconciliation of the beginning and ending balances of Level 3 contingent consideration.

 

     Fair Value  Measurements
Using Significant Unobservable
Inputs (Level 3)
 
     Contingent Consideration  

Beginning balance at December 31, 2010

   $ 16,087,250   

Total gains or losses (unrealized):

  

Included in earnings

     5,078,175   

Milestone payment

     (15,000,000
  

 

 

 

Ending balance at September 30, 2011

   $ 6,165,425   
  

 

 

 

The significant assumptions used in preparing the valuation of the Company’s contingent considerations as of September 30, 2011 include (i) discount rate (35%), (ii) risk-free interest rate (20-year U.S. Treasury yield of 3.4%), (iii) market risk premium (5.5%), (iv) premium for small size (12.7%), and (v) probability of success (100%).

 

8


Oceana Therapeutics, Inc.

Notes to Unaudited Consolidated Financial Statements (continued)

2. Foreign Exchange Forward Contracts (continued)

 

If the Company’s estimates regarding the fair value of these future considerations are inaccurate, a future adjustment to these estimated fair values may be required. Additionally, these estimated fair values could change significantly.

3. Intangible Assets

The intangible assets with definite lives consist of Deflux® and Solesta® patents. These intangible assets are being amortized on the straight-line method over their estimated useful lives of six years. Amortization expense related to intangible assets was approximately $7.9 million and $6.9 million for the periods ended September 30, 2011 and 2010, respectively. Starting June 2011, after approval of Solesta® in the United States, the in-process research and development intangible asset was reclassified to the Solesta intangible asset with a definite life and the Company began amortization of this asset.

The Company’s intangible assets consist of the following (in thousands):

 

     September 30, 2011  
     Gross      Accumulated
Amortization
     Net  

Intangible assets with finite lives:

        

Deflux®

   $ 52,898       $ 18,394       $ 34,504   

Solesta US

     11,702         835         10,867   

Solesta Europe

     9,861         3,405         6,456   
  

 

 

    

 

 

    

 

 

 

Total intangible assets

   $ 74,461       $ 22,634       $ 51,827   
  

 

 

    

 

 

    

 

 

 
     December 31, 2010  
     Gross      Accumulated
Amortization
     Net  

Intangible assets with finite lives:

        

Deflux®

   $ 52,898       $ 12,398       $ 40,500   

Solesta Europe

     9,861         2,300         7,561   
  

 

 

    

 

 

    

 

 

 
     62,759         14,698         48,061   

In-process research and development

     11,702         —           11,702   
  

 

 

    

 

 

    

 

 

 

Total intangible assets

   $ 74,461       $ 14,698       $ 59,763   
  

 

 

    

 

 

    

 

 

 

The weighted average amortization period for intangible assets subject to amortization is four years at September 30, 2011 and five years at December 31, 2010.

 

9


Oceana Therapeutics, Inc.

Notes to Unaudited Consolidated Financial Statements (continued)

 

4. Property and Equipment

Property and equipment consisted of the following at September 30, 2011:

 

     September 30,
2011
    December 31,
2010
 

Auto

   $ 44,913      $ 44,913   

Leasehold improvements

     107,924        104,164   

Office equipment

     84,830        84,830   

Furniture and fixtures

     260,182        260,182   

Computer equipment and software

     387,373        302,935   

Construction in process

     62,243        —     
  

 

 

   

 

 

 
     947,465        797,024   

Less accumulated depreciation

     (503,688     (343,423
  

 

 

   

 

 

 

Property, plant and equipment, net

   $ 443,777      $ 453,601   
  

 

 

   

 

 

 

Included in the net book value of property, plant and equipment at September 30, 2011 was $44,913 of assets financed through an auto loan. Depreciation expense was $160,265 and $166,772 for the periods ended September 30, 2011 and 2010, respectively.

5. Capital Structure

Common Stock

As of September 30, 2011, common stock consisted of the following:

 

     Par
Value
     Authorized,
Issued and
Outstanding

Shares
     Amount  
        

Common stock

   $ 0.0001         100         Nominal   
  

 

 

    

 

 

    

 

 

 

In June 2011, the Company raised $25.0 million of capital funds, the proceeds of which were used to pay the milestone payment due Q-Med Scandinavia Inc. triggered by the approval of Solesta® in the United States and for general corporate purposes. No additional shares were issued as a result of this raise, so all of the funds are considered additional paid-in capital.

 

10


Oceana Therapeutics, Inc.

Notes to Unaudited Consolidated Financial Statements (continued)

5. Capital Structure (continued)

 

Equity Units

During 2009, the Company’s Board of Directors approved an Equity Unit Appreciation Plan (the “2009 Plan”). Pursuant to the 2009 Plan, the Company granted profit interests (the “Equity Units”) to certain of its executives and employees. The Equity Units have two subclasses: Service Units and Performance Units. Subject to forfeiture and participation provisions, as detailed in the 2009 Plan, the holders of Equity Units shall have rights with respect to profits of the Company upon a qualifying event. The Equity Units are not convertible into common stock and are not saleable or generally transferable.

The Company’s Board of Directors approved 4,055,627 Equity Units, as defined, available for grant, of which 3,021,000 Equity Units have been granted. The Equity Units were granted to the holders at no cost.

In total, 16.67% of the Equity Units granted were Service Units and the remaining 83.33% of the Equity Units granted were Performance Units. These grants participate in the Company’s profits only upon certain change of control or liquidation events and only if, upon the occurrence of such an event, Kelso Investment Associates VIII, L.P. receives an internal rate of return, compounded annually, on its investment in Oceana Therapeutics, LLC (“LLC”) of at least 8% and the Final Value, as defined in the Oceana Therapeutics LLC Agreement, is at least greater than 2.0 times the Initial Value, as defined in the Oceana Therapeutics LLC Agreement. All Equity Units will participate in distributions if the Final Value is greater than 4.5 times the Initial Value, and the Equity Units will participate in profits and losses on a ratable basis in the event that the Final Value is greater than 2.0 times, but less than 4.5 times the Initial Value. Equity Units granted to an executive or employee are subject to forfeiture if the executive or employee ceases to be employed by the Company prior to a change in control. Equity Units not eligible to participate in distributions are automatically forfeited.

 

11


Oceana Therapeutics, Inc.

Notes to Unaudited Consolidated Financial Statements (continued)

5. Capital Structure (continued)

 

A summary of the Equity Units granted during the period ended September 30, 2011 is presented below:

 

Service Units

   Units      Grant Date
Fair Value
 

Outstanding Service Units at December 31, 2010

     297,000       $ —     

Granted

     206,500         —     
  

 

 

    

 

 

 

Outstanding Service Units at September 30, 2011

     503,500       $ —     
  

 

 

    

 

 

 

Performance Units

   Units      Grant Date
Fair Value
 

Outstanding Performance Units at December 31, 2010

     1,485,000       $ —     

Granted

     1,032,500         —     
  

 

 

    

 

 

 

Outstanding Performance Units at September 30, 2011

     2,517,500       $ —     
  

 

 

    

 

 

 

No compensation expense will be recognized for the Service Units and Performance Units until a change in equity control is probable as the exercisability and number of units to be received is contingent upon that event. Accordingly, compensation expense relating to the fair value of the Service Units and Performance Units will be measured and recorded upon the occurrence of a change in control. Refer to the value of the unit as described in Note 7.

6. Operating Leases and Commitments

Rent expense under operating leases was $244,569 and $197,232 for the periods ended September 30, 2011 and 2010, respectively.

The Company is contractually obligated to make potential future success-based development, regulatory and commercial milestone payments in conjunction with acquisitions. These payments are contingent upon the occurrence of certain future events. The amount and the probability of contingent payments have been reflected on the Company’s consolidated financial statements. The contingent purchase price adjustment was $5,078,175 and $1,205,438 for the nine months ended September 30, 2011 and 2010, respectively.

If the Company’s estimates regarding the fair value of the future considerations are inaccurate, a future adjustment to these estimated fair values may be required.

 

12


Oceana Therapeutics, Inc.

Notes to Unaudited Consolidated Financial Statements (continued)

 

7. Subsequent Events

On November 8, 2011, LLC announced it had entered into a definitive agreement for the sale of its operating subsidiary, the Company, to Salix Pharmaceuticals. Ltd. The all cash transaction was valued at approximately $313.7 million, less closing expenses of approximately $4.9 million, and was subject to Federal Trade Commission regulatory approval. The transaction was subsequently approved and the transaction closed as of end of day on December 19, 2011 (“Closing”). The approximate $308.8 million earned by the partners of the LLC and employees of the Company was further offset by two escrow reserves totaling approximately $30.9 million, leading to a total net payment of $277.9 million at Closing. All Equity Units granted under the Company’s Equity Unit Appreciation Plan, including the Service Units and the Performance Units, were subject to forfeiture and had no economic value until a qualifying event was realized, which did not take place until Closing. Therefore, no Fair Value was assigned to these Units as of September 30, 2011 and no compensation expense recognized for the nine months ended September 30, 2010 or September 30, 2011. Upon closing of the transaction, the total number of vested Service Units and Performance Units was 4,721,313 and 23,606,565, respectively. The per unit value for both was $2.272.

 

13