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8-K/A - FORM 8-K AMENDMENT - Vaxart, Inc.d465328d8ka.htm
EX-99.3 - UNAUDITED PRO FORMA CONDENSED COMBINED FINANCIAL INFORMATION OF NABI AND BIOTA - Vaxart, Inc.d465328dex993.htm
EX-23.1 - CONSENT OF PRICEWATERHOUSECOOPERS - Vaxart, Inc.d465328dex231.htm
EX-99.1 - AUDITED CONSOLIDATED FINANCIAL STATEMENTS OF BIOTA - Vaxart, Inc.d465328dex991.htm

Exhibit 99.2

Biota Holdings Limited.

Condensed Financial Statements (Unaudited)

Quarter ending September 30, 2012

Contents

 

Consolidated Balance Sheets

     F-2   

Consolidated Statements of Operations

     F-3   

Consolidated Statements of Stockholders’ Equity and Comprehensive Income

     F-4   

Consolidated Statements of Cash Flows

     F-5   

Notes to Consolidated Financial Statements

     F-6   

 

F-1


Biota Holdings Limited.

Consolidated Balance Sheets (Unaudited)

 

          As at September 30,
2012
    As at June 30,
2012
 
     Note    US$’000     US$’000  
ASSETS        

Current assets:

       

Cash and cash equivalents

        47,051        53,790   

Accounts receivable

        4,782        5,966   

Prepayments

        425        636   

Deferred tax assets

        —          —     

Other current assets

        823        738   
     

 

 

   

 

 

 

Total current assets

        53,081        61,130   

Non-current assets:

       

Property, plant and equipment

        14,353        13,982   

Less accumulated depreciation

        (9,680     (9,038
     

 

 

   

 

 

 

Property, plant and equipment — net

        4,673        4,944   
     

 

 

   

 

 

 

Intangible assets

        16,059        15,602   

Less accumulated amortisation

        (14,263     (13,798
     

 

 

   

 

 

 

Intangible assets — net

        1,796        1,804   
     

 

 

   

 

 

 

Deferred tax assets

        1,450        1,419   
     

 

 

   

 

 

 

Total non-current assets

        7,919        8,167   
     

 

 

   

 

 

 

Total assets

        61,000        69,297   
     

 

 

   

 

 

 
LIABILITIES AND STOCKHOLDERS’ EQUITY        

Current liabilities:

       

Accounts payable

        1,803        2,851   

Accrued expenses

        2,729        3,556   

Customer advances

        521        398   

Deferred tax liabilities

        133        130   

Other current liabilities — provisions

        1,801        2,577   
     

 

 

   

 

 

 

Total current liabilities

        6,987        9,512   

Non-current liabilities:

       

Employee entitlements provision

        506        504   
     

 

 

   

 

 

 

Total non-current liabilities

        506        504   
     

 

 

   

 

 

 

Total liabilities

        7,493        10,016   
     

 

 

   

 

 

 

Commitments and contingencies (note 3)

        —          —     
     

 

 

   

 

 

 

Stockholders’ equity:

       

Common stock, No par value. Authorized 182,763,651 shares; Issued 2012: 182,763,651 (2011: 181,703,711)

        100,804        100,394   

Common stock Treasury

        (1,397     (1,397

Additional paid-in capital

        441        668   

Foreign currency translation reserve

        30,802        29,516   

Accumulated deficit

        (69,900     (50,705

Current year loss

        (7,243     (19,195
     

 

 

   

 

 

 

Total stockholders’ equity

        53,507        59,281   
     

 

 

   

 

 

 

Total liabilities and stockholders’ equity

        61,000        69,297   
     

 

 

   

 

 

 

See accompanying notes to the financial statements

 

F-2


Biota Holdings Limited.

Consolidated Statements of Operations and

Comprehensive Income (Unaudited)

 

     Quarter ended September 30,  
     2012     2011  
     US$’000     US$’000  

Revenue

    

Revenue from products

     (16     2,507   

Revenue from services

     1,473        1,611   

Other income

     7        28   
  

 

 

   

 

 

 

Total revenue

     1,464        4,146   

Operating costs & expenses

    

Cost of services

     1,549        1,331   

Research and development

     3,517        4,267   

Product development

     1,084        2,062   

Business development

     360        500   

General and administrative

     2,832        1,298   
  

 

 

   

 

 

 

Total operating costs & expenses

     9,342        (9,458
  

 

 

   

 

 

 

(Loss) from operations

     (7,878     (5,312

Other income/(expense)

    

Interest income

     537        985   
  

 

 

   

 

 

 

Total other income

     537        985   
  

 

 

   

 

 

 

Net loss before tax

     (7,341     (4,327

Income tax benefit

     98        130   
  

 

 

   

 

 

 

Net loss

     (7,243     (4,197
  

 

 

   

 

 

 

Other comprehensive (loss)/income

    

Exchange differences on translation of foreign operations

     1,286        (6,072
  

 

 

   

 

 

 

Other comprehensive expense, net of tax

     1,286        (6,072
  

 

 

   

 

 

 

Total comprehensive (loss)

     (5,957     (10,269
  

 

 

   

 

 

 

Basic net (loss) per share

     (0.04     (0.023

Average weighted number of shares — basic

     182,516,549        181,551,302   

Diluted net (loss) per share

     (0.040     (0.023

Average weighted number of shares — diluted

     182,516,549        181,551,302   

See accompanying notes to the financial statements.

 

F-3


Biota Holdings Limited

Consolidated Statements of Stockholders’ Equity and Comprehensive Income (Unaudited)

 

     Ordinary shares      Additional
Paid-in
Capital
    Accumulated
Deficit
    Treasury
Shares
    Foreign
currency
translation
reserve
    Total
Stockholders’
Equity
 
     Shares      Amount             
    

 

     US$’000      US$’000     US$’000     US$’000     US$’000     US$’000  

Balances at July 1, 2011

     181,417,556         99,805         740        (50,705     (968     32,556        81,428   

Comprehensive income

                

Exchange differences on translation of foreign operations

                 (6,072     (6,072 )

Net loss

             (4,197         (4,197
                

 

 

 

Total Comprehensive income

             (4,197       (6,072     (10,269
                

 

 

 

Exercise of stock options to employees

     286,155         353         (353           —     

Purchase of Treasury shares

                   —     

Stock option expense

           353              353   
  

 

 

    

 

 

    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Balances at September 30, 2011

     181,703,711         100,158         740        (54,902     (968     26,484        71,512   
  

 

 

    

 

 

    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Balances at July 1, 2012

     182,350,316         100,394         668        (69,900     (1,397     29,516        59,281   

Comprehensive income

                

Exchange differences on translation of foreign operations

                 1,286        1,286   

Net loss

             (7,243         (7,243
                

 

 

 

Total Comprehensive income

             (7,243       1,286        (5,957
                

 

 

 

Exercise of stock options to employees

     413,335         410         (410           —     

Purchase of Treasury shares

                   —     

Stock option expense

           183              183   
  

 

 

    

 

 

    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Balances at September 30, 2012

     182,763,651         100,804         441        (77,143     (1,397     30,802        53,507   
  

 

 

    

 

 

    

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

See accompanying notes to the financial statements.

 

F-4


Biota Holdings Limited.

Consolidated Statements of Cash Flows (Unaudited)

 

     Quarter ended September 30,  
     2012     2011  
     US$’000     US$’000  

Cash flows from operating activities provided by/(used in):

    

Net loss

     (7,243     (4,197

Adjustments to reconcile net profit/(loss) to net cash provided by/(used in) operating activities:

    

Depreciation and amortization

     615        684   

Share based payments expense

     147        94   

Change in assets and liabilities:

    

Accounts receivables

     1,408        (2,150

Prepaid expenses and other current assets

     62        95   

Deferred tax assets

     (40     (129

Deferred revenue

     114        26   

Employee entitlements

     (842     (700

Accounts payable and accrued expenses

     (2,014     (1,190
  

 

 

   

 

 

 

Net cash used in operating activities

     (7,793     (7,467
  

 

 

   

 

 

 

Cash flows from investing activities:

    

Purchases of property, plant and equipment

     (188     (374
  

 

 

   

 

 

 

Net cash used in investing activities

     (188     (374
  

 

 

   

 

 

 

Cash flows from financing activities:

    

Net cash provided by financing activities

     —          —     
  

 

 

   

 

 

 

Net decrease in cash and cash equivalents

     (7,981     (7,841

Cash and cash equivalents at beginning of period

     53,790        74,177   

Effects of exchange rate movements on cash and cash equivalents

     1,242        (5,055
  

 

 

   

 

 

 

Cash and cash equivalents at end of period

     47,051       61,281   
  

 

 

   

 

 

 

See accompanying notes to the financial statements.

 

F-5


Biota Holdings Limited.

Notes to Consolidated Financial Statements (Unaudited)

(for the quarters ended September 30, 2011 and 2012)

(1) Basis of Presentation

In the opinion of management, the accompanying condensed consolidated financial statements include all adjustments, consisting of normal recurring adjustments, which are necessary to a fair presentation of our financial position, results of operations and cash flows. The condensed consolidated financial data as of September 30, 2012 and for the three months ended September 30, 2012 and September 30, 2011 is unaudited. The condensed consolidated balance sheet at June 30, 2012, has been derived from audited consolidated financial statements as of that date included in the Current Report on Form 8-K/A filed on January 21, 2013. The interim results of operations are not necessarily indicative of the results that may occur for the full fiscal year. Certain information and footnote disclosure normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America (U.S. GAAP) have been condensed or omitted pursuant to instructions, rules and regulations prescribed by the U.S. Securities and Exchange Commission. We believe that the disclosures provided herein are adequate to make the information presented not misleading when these condensed consolidated financial statements are read in conjunction with the Consolidated Financial Statements and Notes included in our financial statements for the year ended June 30, 2012, included in the Current Report on Form 8-K/A filed on January 21, 2013.

All amounts are expressed in US Dollars (“USD” or “US$”) unless otherwise stated. Amounts included in tables are rounded to the nearest thousand dollars.

The Company’s consolidated financial statements comprise Biota Holdings Limited and its subsidiaries and have been prepared assuming the Company will continue as a going concern. We rely largely on our existing cash and cash equivalents and operating cash flow to provide for the working capital needs of our operations. We believe we have sufficient cash and cash equivalents to fund our operations for at least the next twelve months. However, in the event, our financing needs for the foreseeable future are not able to be met by our existing cash and cash equivalents and operating cash flow, we would seek to raise funds through public or private equity offerings, debt financings, and through other means to meet the financing requirements. There is no assurance that funding would be available at acceptable terms, if at all.

 

(2) Summary of Significant Accounting Policies

Principles of Consolidation

The consolidated financial statements include the financial statements of the Company and its wholly owned subsidiaries. All intercompany balances and transactions have been eliminated on consolidation.

Use of Estimates

The preparation of the consolidated financial statements requires management of the Company to make a number of estimates and assumptions relating to the reported amount of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the period. Significant items subject to such estimates and assumptions include the carrying amount of property, plant and equipment, intangible assets, deferred income taxes, and obligations related to employee benefits. Actual results could differ from those estimates.

Cash & Cash Equivalents

The Company considers all highly liquid investments purchased with an initial maturity of three months or less to be cash equivalents. For cash and cash equivalents, the carrying amount approximates fair value due to the short maturity of those instruments.

Short-Term Investments

Short-term investments constitute all highly liquid investments with term to maturity from three months to twelve months. The carrying amount of short-term investments is equivalent to its fair value.

 

F-6


Biota Holdings Limited.

Notes to Consolidated Financial Statements (Unaudited)

(for the quarters ended September 30, 2011 and 2012)

 

Concentration of Credit Risk and Other Risks and Uncertainties

Cash and cash equivalents and accounts receivables consists of financial instruments that potentially subject the Company to concentration of credit risk to the extent of the amount recorded on the balance sheet. The Company’s cash and cash equivalents are invested primarily with Australia’s largest banks. The Company is exposed to credit risk in the event of default by the banks holding the cash or cash equivalents to the extent of the amount recorded on the balance sheets. The Company has not experienced any losses on its deposits of cash and cash equivalents. The Company’s receivables are primarily from GlaxoSmithKline (GSK), Daiichi Sankyo and the U.S. Office of Biomedical Advanced Research and Development Authority (BARDA). The Company has not identified any collectability issues with respect to receivables.

Derivative Instruments and Hedging Activities

Derivative financial instruments

The Company may use derivative financial instruments to hedge its exposure to foreign exchange arising from operating, investing and financing activities. The Company does not hold or issue derivative financial instruments for trading purposes. However, derivatives that do not qualify for hedge accounting are accounted for as trading instruments.

Derivative financial instruments are recognized initially at fair value. Subsequent to initial recognition, derivative financial instruments are stated at fair value. The gain or loss on remeasurement to fair value is recognized immediately in the statement of operations. However, where derivatives qualify for hedge accounting, recognition of any resultant gain or loss depends on the nature of the item being hedged.

Cash flow hedges

Exposure to foreign exchange risks arises in the normal course of the Company’s business and it is the Company’s policy to hedge anticipated sales and purchases in foreign currencies. The amount of forward cover taken is in accordance with approved policy and internal forecasts.

Where a derivative financial instrument is designated as a hedge of the variability in cash flows of a recognized asset or liability, or a highly probable forecast transaction, the effective part of any unrealised gain or loss on the derivative financial instrument is recognized directly in equity. When the forecast transaction subsequently results in the recognition of a non-financial asset or non-financial liability, the associated cumulative gain or loss is removed from equity and included in the initial cost or other carrying amount of the non-financial asset or liability.

For cash flow hedges, other than those covered by the preceding statement, the associated cumulative gain or loss is removed from equity and recognized in the consolidated statements of operations in the same period or periods during which the hedged forecast transaction affects the consolidated statements of operations and on the same line item as that hedged forecast transaction. The ineffective part of any gain or loss is recognized immediately in the consolidated statements of operations.

When a hedging instrument expires or is sold, terminated or exercised, or the Company revokes designation of the hedge relationship but the hedged forecast transaction is still probable to occur, the cumulative gain or loss at that point remains in equity and is recognized in accordance with the above policy when the transaction occurs. If the hedged transaction is no longer expected to take place, then the cumulative unrealized gain or loss recognized in equity is recognized immediately in the consolidated statements of operations.

 

F-7


Biota Holdings Limited.

Notes to Consolidated Financial Statements (Unaudited)

(for the quarters ended September 30, 2011 and 2012)

 

Receivables

Trade accounts receivable are recorded at the invoiced amount and do not bear interest. The allowance for doubtful accounts is the best estimate of the amount of probable credit losses in the existing accounts receivable. The allowance is determined based on a review of individual accounts for collectability, generally focusing on those accounts that are past due. The current year expense to adjust the allowance for doubtful accounts, if any, is recorded within the underlying departmental expenses in the consolidated statements of operations. An allowance for uncollectible trade receivables is estimated based on a combination of write-off history, aging analysis and any specific, known troubled accounts. When a receivable is finally established as uncollectible, it is written off against the allowance account for accounts receivable.

 

     September 30,
2012
     June 30,
2012
 
     US$’000      US$’000  

Accounts receivable

     4,782         5,966   

Allowance for doubtful debts

     —           —     
  

 

 

    

 

 

 
     4,782         5,966   
  

 

 

    

 

 

 

Property, Plant, and Equipment

Property, plant, and equipment are recorded at acquisition cost, less accumulated depreciation and impairment.

Depreciation on plant and equipment is calculated using the straight-line method over the estimated useful lives of the assets. The estimated useful life of machinery and equipment is 3 to 10 years. Leasehold improvements are amortized on the straight-line method over the shorter of the remaining lease term or estimated useful life of the asset. Maintenance and repairs are charged to operations as incurred and include normal services and does not include items of a capital nature.

Intangible Assets

Intangible assets comprise two elements:

 

(i) Royalty prepayment

Royalty prepayments represent expenditure to CSIRO and the former Victorian College of Pharmacy where the parties agreed to exchange variable royalty payments in relation to intellectual property, for a fixed payment. They have a finite useful life, usually being the period to the patent or contract expiry and are carried at the present value of costs at acquisition date less accumulated amortisation. Amortisation is based on the anticipated usage of the asset, determined with reference to expected sales of the related product over the contract or product life.

 

(ii) Computer software

Costs incurred in acquiring software and licenses that will contribute to future period financial benefits are capitalised to computer software. Amortisation is calculated on a straight-line basis over periods ranging from one (1) to three (3) years.

Research and Product Development

The Statement of Operations separates Research costs and Product development costs. Research costs are Intellectual Property management, Drug Discovery (chemistry, virology, microbiology, ADME and biochemistry), Drug Target Discovery (molecular biology and modelling and structural biology), specialised information systems and facility costs. Product development costs are clinical and non-clinical development, regulatory affairs, medical affairs, quality assurance, grants management and facility costs. Research and Product development costs are expensed as incurred.

Research and Product development expenses include direct labour costs as well as the costs of contractors and other direct expenses. It does not include an allocation of the costs of facilities or overhead allocation.

During this and previous fiscal years, Biota has received reimbursement for Research and Product development activities from collaboration partners as well as from government grants. Where such expenditure is directly related to these income streams it has been classified as Cost of services within the statement of operations.

 

F-8


Biota Holdings Limited.

Notes to Consolidated Financial Statements (Unaudited)

(for the quarters ended September 30, 2011 and 2012)

 

Research and Product development expenses for quarter ended September 30, 2011 and 2012 are as follows:

 

     Quarter ending September 30,  
     2012      2011  
     US$’000      US$’000  

Research and development expenses

     3,517         4,267   

Product development expenses

     1,084         2,062   
  

 

 

    

 

 

 

Total

     4,601         6,329   
  

 

 

    

 

 

 

Income Taxes

The Company applies ASC 740 — Income Taxes which establishes financial accounting and reporting standards for the effects of income taxes that result from a company’s activities during the current and preceding years. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carry forwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date.

Where it is more likely than not that some portion or all of the deferred tax assets will not be realized the deferred tax assets are reduced by a valuation allowance. The valuation allowance is sufficient to reduce the deferred tax assets to the amount that is more likely than not to be realized.

Impairment of Long-lived Assets

The Company reviews its capital assets, including patents and licenses, for impairment whenever events or changes in business circumstances indicate that the carrying amount of the assets may not be fully recoverable. In performing the review, the Company estimates undiscounted cash flows from products that are covered by these patents and licenses. An impairment loss would be recognized when estimated undiscounted future cash flows expected to result from the use of the asset and its eventual disposition is less than the carrying amount of the asset. If the evaluation indicates that the carrying value of an asset is not recoverable from its undiscounted cash flows, an impairment loss is measured by comparing the carrying value of the asset to its fair value.

Australian Goods and Services Tax (GST)

Revenues, expenses and assets are recognized net of the amount of associated GST, where the GST incurred is not recoverable from the taxation authority, it is recognized as part of the cost of acquisition of the asset or as part of the expense. Receivables and payables are stated exclusive of the amount of GST receivable or payable. The net amount of GST recoverable from, or payable to, the taxation authority is included with other receivables or payables in the balance sheet.

Revenue Recognition

Our revenue generating arrangements may include multiple elements and deliverables, including licenses, options, research and development activities, participation on joint steering committees and royalties or profit share arrangements, among other elements. We also receive funding for research and development activities from governmental and non-governmental agencies in the form of contracts or grants.

For arrangements entered into prior to July 1, 2010, when we determine that an element has stand-alone value to our customer, we allocate a portion of the total contract price to that element based on its objectively determined and relative fair value, and recognize revenue for that element according to its characteristics. When we cannot reliably and objectively determine fair value of any delivered element, we combine that element with undelivered elements as a single unit of accounting.

 

F-9


Biota Holdings Limited.

Notes to Consolidated Financial Statements (Unaudited)

(for the quarters ended September 30, 2011 and 2012)

 

For arrangements entered into or materially modified after June 30, 2010, when we determine that an element has stand-alone value to our customer, we allocate a portion of the total contract price to that element based on its relative selling price, determined pursuant to a selling price hierarchy, and recognize revenue for that element according to its characteristics.

Revenue from products consists of royalty payments. Revenue from services includes license fees, milestone payments, and payments for contractual services.

Revenue from royalties is recognised upon sales of the underlying product by the relevant third party. The Company receives written confirmation of these royalties quarterly. The Company receives royalties in relation to two products.

Biota’s first royalty-producing product, zanamivir, was developed and commercialized as the first-in-class neuraminidase inhibitor (NI) to treat influenza pursuant to a research and license agreement entered into with GSK in 1990. Under the terms of the agreement, Biota licensed zanamivir on an exclusive, worldwide basis to GSK, which markets the product as Relenza. Under the agreement, Biota receives royalty payments of 7% of GSK’s annual net sales of Relenza in major countries and 10% of GSK’s annual net sales of Relenza in Australia, New Zealand, South Africa and Indonesia.

Biota’s second royalty-producing product is Inavir®, a second-generation NI, which was developed in collaboration with Daiichi Sankyo, pursuant to a collaboration and license agreement which provides for the cross-licensing of NI patents and other information relating to long acting NI (“LANI”) drugs, including laninamivir. Under the collaboration and license agreement, Biota and Daiichi Sankyo agreed to share equally any royalties, license fees, or milestone or other payments received from any third party licences outside of Japan.

In September 2010, Inavir® was approved by the Japanese Ministry of Health and Welfare for the treatment of influenza in adults and children, which enabled Daiichi Sankyo to initially market the product for the 2010/2011 influenza season. Daiichi Sankyo is currently seeking the right to market and manufacture Inavir® for prevention purposes following the completion of a Phase III prevention study in Japan. Under the agreement with Daiichi Sankyo, Biota currently receives a 4% royalty on Daiichi Sankyo’s net sales of Inavir®.

License fees received are initially recorded as deferred revenue, and are subsequently recognized as revenue ratably over the period of our contractual commitment to participation in a project. Our efforts under the arrangements with AstraZeneca in relation to the RSV project and with Boehringer Ingelheim related to a HCV project were completed in fiscal 2010; accordingly, we have fully recognized the up-front payment related to these agreements. No further licence fees have been received by the Company.

Revenue for research and development services typically consist of payments when specific milestones are met and payments for contractual services during the term of the arrangement.

For milestones that are deemed substantive, we recognize the contingent revenue when: (i) the milestones have been achieved; (ii) no further performance obligations with respect to the milestones exist; and (iii) collection is reasonably assured. A milestone is considered substantive if all of the following conditions are met: (i) the milestone is non-refundable; (ii) achievement of the milestone was not reasonably assured at the inception of the arrangement; (iii) substantive effort is involved to achieve the milestone; and (iv) the amount of the milestone appears reasonable in relation to the effort expended with the other milestones in the arrangement and the related risk associated with achievement of the milestone. If a milestone is deemed not to be substantive, the Company would recognize the portion of the milestone payment as revenue that correlates to work already performed; the remaining portion of the milestone payment will be deferred and recognized as revenue as the Company completes its performance obligations.

Payments for contractual services are recognized as revenue when earned, typically when the services are rendered. We analyze cost reimbursable grants and contracts to determine whether we should report such reimbursements as revenue or as an offset to research and development expenses incurred.

 

F-10


Biota Holdings Limited.

Notes to Consolidated Financial Statements (Unaudited)

(for the quarters ended September 30, 2011 and 2012)

 

Collaborative arrangements

For costs incurred and revenues generated from third parties where we are deemed to be the principal participant, we recognize revenues and costs using the gross basis of accounting; otherwise we use the net basis of accounting.

On March 31, 2011, the Company’s wholly owned subsidiary, Biota Scientific Management Pty Ltd. (“BSM”), was awarded a contract by BARDA. BARDA is part of the U.S. Office of the Assistant Secretary for Preparedness and Response (“ASPR”) within the U.S. Department of Health and Human Services (“HHS”). The BARDA contract is for the late stage development of laninamivir on a cost-plus-fixed-fee basis, not to exceed $231,252,675 (of which $15,128,679 represents BSM’s fixed-fee and $216,123,996 represents the estimated costs reimbursable by BARDA). Pursuant to the BARDA contract, reimbursable costs include those costs incurred by BSM for manufacturing, a pilot clinical evaluation, scale-up development, and manufacturing facility design (but not facility construction) leading towards licensure of laninamivir by the FDA. The BARDA contract is designed to fund and provide BSM with technical and clinical data and U.S. based manufacturing to support a U.S. new drug application (“NDA”) to the FDA for laninamivir. The performance period of the BARDA contract commenced on March 31, 2011, and continues for 60 months. As of September 30, 2012, Biota Scientific Management has been paid $2,435,931 by BARDA in three (3) months to September 30, 2012.

We are an active participant with exposure to significant risks and rewards of commercialization relating to the development of laninamivir and therefore recognise revenues and costs on a gross basis.

Foreign Currency

Functional and reporting currency

Items included in the financial statements of each of the Group’s entities are measured using the currency of the primary economic environment in which the entity operates (“the functional currency”). The functional currency of the Company is AUD or A$ for all years presented.

The consolidated financial statements are presented using a reporting currency of US dollars.

Transactions and balances

Foreign currency transactions are translated into the functional currency using the exchange rates prevailing at the dates of the transactions. Foreign exchange gains and losses resulting from the settlement of such transactions and from the translation at year-end exchange rates of monetary assets and liabilities denominated in foreign currencies are recognized in the consolidated statements of operations.

The Company has recorded foreign currency transaction loss /(gain)of $74,007 and ($31,668) in each of the quarters ended September 30, 2012 and 2011, respectively.

The results and financial position of all the Group entities that have a functional currency different from the reporting currency are translated into the reporting currency as follows:

 

   

assets and liabilities for each balance sheet item reported are translated at the closing rate at the date of that balance sheet;

 

   

income and expenses for each statement of operations are translated at average exchange rates (unless this is not a reasonable approximation of the effect of the rates prevailing on the transaction dates, in which case income and expenses are translated at the dates of the transactions); and

 

   

all resulting exchange differences are recognized as a separate component of equity accumulated other comprehensive income.

On consolidation, exchange differences arising from the translation of any net investment in foreign entities are taken to the Foreign Currency Translation Reserve net of related taxes.

 

F-11


Biota Holdings Limited.

Notes to Consolidated Financial Statements (Unaudited)

(for the quarters ended September 30, 2011 and 2012)

 

Commitments and Contingencies

Liabilities for loss contingencies, arising from claims, assessments, litigation, fines, and penalties and other sources are recorded when it is probable that a liability has been incurred and the amount of the assessment can be reasonably estimated. These were nil as at September 30, 2012 (2011:nil).

Patent and License Costs

Legal fees incurred for patent application costs have been charged to expense and reported in research and development expense. Legal fees incurred for patents relating to commercialized products are capitalized and amortized over the life of the patents.

Clinical Trial Expenses

Clinical trial costs are a component of research and development expenses. These expenses include fees paid to participating hospitals and other service providers, which conduct certain testing activities on behalf of the Company. Depending on the timing of payments to the service providers and the level of service provided, the Company records prepaid or accrued expenses relating to these costs.

These prepaid or accrued expenses are based on estimates of the work performed under service agreements.

Leased Assets

The company accounts for our lease agreements pursuant to ASC840 Leases, which categorizes leases at their inception as either operating or capital leases depending on certain defined criteria. All of the Company’s leases for the quarters ended September 30, 2012 and 2011 are considered operating leases. The costs of operating leases are charged to the statement of operations on a straight-line basis over the lease term. Additionally, incentives we receive are treated as a reduction of our costs over the term of the agreement. Leasehold improvements are capitalized at cost and amortized over the lesser of their expected useful life or the life of the lease, without assuming renewal features, if any, are exercised.

Stock-based Compensation

We measure stock-based compensation at grant date, based on the estimated fair value of the award, and recognize the cost as an expense on a straight-line basis over the vesting period of the award. We estimate the fair value of stock options issued as part of the Company’s long-term incentive plan using the Monte Carlo model. We also grant our employees Zero Exercise-Price Options (“ZEPOs”). ZEPOs are stock options granted to employees that entitle the holder to shares of common stock when the award vests at no cost. The value of ZEPOs are determined and fixed on the grant date based on the Company’s stock price. See note 5 for further details.

We record deferred tax assets for awards that will result in deductions on our income tax returns, based on the amount of compensation cost recognized and our statutory tax rate in the jurisdiction in which we will receive a deduction. Differences between the deferred tax assets recognized for financial reporting purposes and the actual tax deduction reported in our income tax return are recorded in expense or in capital in excess of par value if the tax deduction exceeds the deferred tax assets or to the extent that previously recognized credits to paid-in-capital are still available if the tax deduction is less than the deferred tax asset.

Employee Benefit Costs

The Company contributes to standard defined contribution superannuation funds on behalf of all employees at nine percent of each such employee’s salary. Superannuation is a compulsory savings program whereby employers are required to pay a portion of an employee’s remuneration to an approved superannuation fund that the employee is typically not able to access until they are retired. The Company permits employees to choose an approved and registered superannuation fund into which the contributions are paid. Contributions are charged to the statement of operations as they become payable.

 

F-12


Biota Holdings Limited.

Notes to Consolidated Financial Statements (Unaudited)

(for the quarters ended September 30, 2011 and 2012)

 

Net Profit/(Loss) per Share and Anti-dilutive Securities

Basic and diluted net profit/(loss) per share is presented in conformity with ASC 260 – Earnings per Share. Basic and diluted net profit/(loss) per share has been computed using the weighted-average number of common shares outstanding during the period. Other than in a profit making year, the potentially dilutive options issued under the Biota Employee Option Plan were not considered in the computation of diluted net profit/(loss) per share because they would be anti-dilutive given the Company’s loss making position.

Total Comprehensive Income

The Company follows ASC 220 – Comprehensive Income. Comprehensive income is defined as the total change in shareholders’ equity during the period other than from transactions with shareholders, and for the Company, includes net income and cumulative translation adjustments.

Recent Accounting Standards

In June 2011, the FASB issued ASU No. 2011-05, Comprehensive Income (Topic 220): Presentation of Comprehensive Income. The new guidance allows an entity to present components of net income and other comprehensive income in one continuous statement, referred to as the statement of comprehensive income, or in two separate, but consecutive statements. The guidance eliminates the current option to report other comprehensive income and its components in the statement of changes in equity. While the new guidance changes the presentation of comprehensive income, there are no changes to the components that are recognized in net income or other comprehensive income under current accounting guidance. The Company adopted the provisions of ASU 2011-05 in the first quarter of 2012 and has presented a single statement of comprehensive income.

In May 2011, the FASB issued ASU No. 2011-04, Fair Value Measurement (Topic 820): Amendments to Achieve Common Fair Value Measurement and Disclosure Requirements in U.S. generally accepted accounting principles (GAAP) and International Financial Reporting Standards (IFRS). This ASU is intended to result in convergence between U.S. GAAP and IFRS requirements for measurement of and disclosures about fair value. The guidance amends current fair value measurement and disclosure guidance to include increased transparency around valuation inputs and investment categorization. The Company adopted the provisions of ASU 2011-04 in the first quarter of 2012. Adoption of the new guidance did not have an impact on the company’s consolidated financial statements.

Recent Accounting Pronouncements

In December 2011, the FASB issued ASU 2011-11 which amended the disclosure requirements regarding offsetting assets and liabilities of derivatives, sale and repurchase agreements, reverse sale and repurchase agreements, and securities borrowing and securities lending arrangements. The enhanced disclosures will require entities to provide both net and gross information for these assets and liabilities. The amendment is effective for fiscal years beginning on or after January 1, 2013. The Company does not anticipate that this amendment will have a material impact on its financial statements.

 

F-13


Biota Holdings Limited.

Notes to Consolidated Financial Statements (Unaudited)

(for the quarters ended September 30, 2011 and 2012)

 

(3) Commitments and Contingent Liabilities

Operating Leases

The Company has two principal leases in respect to premises.

The lease at 585 Blackburn Road, Notting Hill, Victoria houses the main Biota laboratories. The lease commenced in September 2004 and was last amended in December 2007. The lease term expires on September 1, 2014 and the Company has the option at that time to extend this lease for a further term of 5 years at an agreed market rate.

The lease at 597 Blackburn Road, Notting Hill, Victoria commenced on November 2007 and expires on July 30, 2013. Under the term of the lease, a security deposit of A$125,000 has been paid and has been recorded under “Other Assets” in the Consolidated Balance sheets. In accordance with the terms of the lease, the lessee has to restore the building to its original condition and the lessor can deduct costs from the security cost.

Future minimum lease payments under non-cancellable operating leases (with initial or remaining lease terms in excess of one year) as of September 30, 2012 are:

 

     US$’000  

2013

     558   

2014

     323   

2015

     49   

2016 and thereafter

     —     
  

 

 

 

Total minimum lease payments

     931   
  

 

 

 

Rent expense was $210,659 and $242,921 for the quarters ended September 30, 2012 and 2011, respectively.

Government Research Grants

In 2006, Biota was awarded a grant of US$8.5 million by the National Institute of Allergy and Infectious Diseases, an institute of National Institutes of Health (NIH). The award was to develop a class of long-acting neuraminidase inhibitors (LANI), called FLUNET. This grant was completed in 2011.

In 2011, Biota was awarded a grant of US$2.9 million by the National Institute of Allergy and Infectious Diseases, an institute of National Institutes of Health (NIH). This grant is to fund the Preclinical development of a lead candidate for the treatment of Clostridium Difficile (C diff).

All payments under NIH grants are subject to satisfactory progress and the availability of funding.

Grant funding is initially recognised as deferred income and released to revenue to match the costs that they are intended to compensate for. Revenue recognised in relation to these grants was $148,591 and $185,187 for the quarters to September 30, 2012 and 2011 respectively.

Guarantees

There are cross guarantees given by Biota Holdings Limited and Biota Scientific Management Pty Ltd. No deficiencies of assets exist in any of these companies. No liability was recognized by the parent entity or the consolidated entity in relation to this guarantee, as the fair value of the guarantees is immaterial.

 

F-14


Biota Holdings Limited.

Notes to Consolidated Financial Statements (Unaudited)

(for the quarters ended September 30, 2011 and 2012)

 

(4) Income Taxes

The Company is subject to income tax in Australia and the United Kingdom and is required to pay taxes on its Australian and United Kingdom profits. As provided under the Australian income tax laws, the Company and its wholly owned resident subsidiary have formed a tax-consolidated group. A reconciliation of the (benefit)/provision for income taxes with the amount computed by applying the Australian and United Kingdom statutory company tax rate of 30% to the profit/(loss) before income taxes is as follows:

 

     Quarter ended September 30,  
     2012            2011        
     US$’000     %      US$’000     %  

Loss before income taxes

     (7,340        (4,327  

Computed by applying income tax rate of home jurisdiction

     2,202        30         1,298        30   

Research & development incentive

     (426     30         (586     30   

UK Research & development incentive

     (285     20         —          20   

Disallowed expenses/(income):

         

Share based payment

     (56     30         (123     30   

Non-taxable amortisation

     142        30         (430     30   

Other

     (433     30         (29     30   

UK tax losses & differences not recognised

     99        30         —          30   

Change in valuation allowance

     (1,145     30         —       
  

 

 

      

 

 

   

Income tax benefit

     98           130     
  

 

 

      

 

 

   

Significant components of the Company’s deferred tax assets are shown below:

 

     September 30,
2012
    June 30,
2012
 
     US$’000     US$’000  

Deferred tax assets:

    

Operating loss carry forwards

     21,110        21,121   

Unrealised foreign exchange losses

     (20     (19

Employee entitlements

     922        902   

Intangibles

     924        904   

Accruals

     874        855   

Deferred revenue

     122        120   

Blackhole expenses

     286        281   

Property, plant and equipment

     85        83   

Prepayments

     (7     (7

Accrued Income

     (1,869     (1,830
  

 

 

   

 

 

 

Total deferred tax assets

     1,317        22,410   

Valuation allowance for deferred tax assets

     (21,110     (21,121
  

 

 

   

 

 

 

Net deferred tax asset

     1,317        1,289   
  

 

 

   

 

 

 

Significant components of deferred income taxes reflect the net tax effect of temporary differences between the carrying amounts of assets and liabilities for financial reporting and tax purposes. A valuation allowance has been established, as realization of such assets is not more likely than not.

At September 30, 2012 the Company has accumulated Australian tax losses of A$56,672,000 and accumulated UK tax losses of A$26,772,000 available for carry forward against future earnings, which under relevant tax laws do not expire but may not be available under certain circumstances. A full valuation allowance has been established against these tax losses due to the volatility of earnings and the potential unavailability of the losses in some circumstances, including changes in ownership. The assets not subject to a valuation allowance relate to temporary differences arising on Australian balance sheet amounts, which are currently expected to reverse in a year where sufficient Australian taxable profit will be available to utilise them.

 

F-15


Biota Holdings Limited.

Notes to Consolidated Financial Statements (Unaudited)

(for the quarters ended September 30, 2011 and 2012)

 

(5) Employee Incentive Schemes

a) Stock Option Plan

In 2004, the Company adopted the Biota Employee Option Plan (“Plan”). The Plan ceased and all available options vested due to the merger with Nabi Biopharmaceuticals described in note 8. Options could be granted pursuant to the Plan to any person considered by the board to be employed by the Group on a permanent basis (whether full time, part time or on a long term casual basis). Each option gives the holder the right to subscribe for one share of common stock. The total number of options that could be issued under the Plan is such maximum amount permitted by law and the Listing Rules of the Australian Securities Exchange (“ASX”). The exercise price and any exercise conditions are determined by the board at the time of grant of the options. Any exercise conditions must be satisfied before the options vest and become capable of exercise. The options lapse on such date determined by the board at the time of grant or earlier in accordance with the Plan. The Plan had three elements; namely (a) Equity Retention Incentive composed of Zero Exercise-Price Options; (b) Total Shareholder Return (TSR) composed of performance rights linked to relative and absolute total shareholder return; and (c) Deferred Bonus Plan which follows the TSR incentive but can be settled in cash as well as in equity.

686,365 options were granted under the Equity Retention Incentive in the quarter ended September 30, 2012. No other options were granted.

The fair value of the Equity Retention Incentive grants are determined using the share price at allocation date. The assumptions for these grants were:

 

Grant date

(A$)

   Exercise Price
(A$)
  

Share Price
@ Grant date

(A$)

  

Volatility

(%)

   Expected Life
(years)
  

Risk Free

Interest Rate

(%)

  

Fair Valuation

of Options

(A$)

24/08/2012

   Nil    $1.00    n/a    0    n/a    1.00

Key elements of the options granted are as follows.

Time to Expiry

All options granted under our share option plan have a maximum five (5) year term and are non-transferable.

 

F-16


Biota Holdings Limited.

Notes to Consolidated Financial Statements (Unaudited)

(for the quarters ended September 30, 2011 and 2012)

 

Activity

Stock option activity during the current period is as follows:

 

     Number of
shares
    Weighted average
share price at
exercise date
 
           A$  

Balance at June 30, 2012

     6,182,853     

Granted

     686,365     

Exercised

     (413,335     0.84   

Lapsed

     (601  
  

 

 

   

Balance at September 30, 2012

     6,455,282     
  

 

 

   

At September 30, 2012, the number of options exercisable was 94,222. At September 30, 2012, total stock compensation expense recognized in income statement was $147,093 (2011: $94,058).

The table below sets forth the number of employee stock options exercised and the number of shares issued in the period.

 

Period Ending

   Number of Options
Exercised and
Corresponding
Number of  Shares
Issued
     Weighted Average
Exercise Price
     Proceeds
Received
 
            US$      US$  

September 30, 2012

     413,335         Nil         Nil   
  

 

 

       

 

 

 

Total

     699,490         Nil         Nil   
  

 

 

       

 

 

 

As of September 30, 2012, there was $1,615,668 of unrecognized compensation expense related to unvested share-based compensation arrangements under the Biota Employee Option Plan. This expense is expected to be recognized as follows:

 

Fiscal Year

   US$’000  

2013

     1,616   
  

 

 

 

Status of options

On approval of the merger with Nabi Biopharmaceuticals by the Supreme Court of Victoria all options under the Plan vested on 9 November 2012 and the related expense (as shown above) was recognised in full due to the acceleration of vesting. Further details of the merger are provided at note 8.

 

F-17


Biota Holdings Limited.

Notes to Consolidated Financial Statements (Unaudited)

(for the quarters ended September 30, 2011 and 2012)

 

(6) Financial Instruments

Financial Assets

 

     September 30,
2012
     June 30,
2012
 
     US$’000      US$’000  

Financial assets:

     

Cash and cash equivalents

     47,051         53,790   

Accounts receivables

     4,782         5,966   
  

 

 

    

 

 

 

Total financial assets

     51,833         59,756   
  

 

 

    

 

 

 

Financial liabilities:

     

Accounts payable

     1,803         2,851   
  

 

 

    

 

 

 

Total financial liabilities

     1,803         2,851   
  

 

 

    

 

 

 

Net financial assets

     50,030         56,905   
  

 

 

    

 

 

 

The carrying value of the cash and cash equivalents, accounts receivable and accounts payable approximates fair value because of their short-term nature.

We regularly review all our financial assets for impairment. There were no impairments recognized in 2012 and 2011.

 

(7) Segments

We review our business from a divisional perspective (ie Research, Product Development and Corporate) and on a project basis. All projects are anti-infective drug discovery and clinical development activities and so represent one (1) reportable business segment. The Group operates globally in developing its projects and has laboratories in Australia and England.

The business segment information provided to the strategic steering committee for the reportable segments for the quarters ended September 30, 2012 and 2011 are set out in the table below:

 

Divisions    Research     Product Development     Corporate      Intersegment elimination     Total  
     2012
US$’000
    2011
US$’000
    2012
US$’000
    2011
US$’000
    2012
US’000
    2011
US$’000
     2012
US$’000
     2011
US$’000
    2012
US$’000
    2011
US$’000
 

External revenue

     155        95        1,326        1,535        (17     2,516         —           —          1,464        4,146   

Intersegment revenue

     —          —          —          —          —          1,382         —           (1,382     —          —     
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

    

 

 

    

 

 

   

 

 

   

 

 

 

Total segment revenue

     155        95        1,326        1,535        (17     3,898         —           (1,382     1,464        4,146   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

    

 

 

    

 

 

   

 

 

   

 

 

 

EBITDA

     (3,011     (3,795     (1,101     (1,728     (2,998     993         —           —          (7,110     (4,530
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

    

 

 

    

 

 

   

 

 

   

 

 

 

Depreciation & amortisation

     414        417        18        4        182        262         —           —          614        683   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

    

 

 

    

 

 

   

 

 

   

 

 

 

Whilst the Group advances its programs globally, it has assets in two (2) geographical locations. The following table sets out the location of the Group’s non current assets:

 

     Australia      England      Total  
     September
30, 2012
US$’000
     June 30,
2012
US$’000
     September
30, 2012
US$’000
     June 30,
2012
US$’000
     September
30, 2012
US$’000
     June 30,
2012
US$’000
 

Non current assets

     7,741         7,977         178         190         7,919         8,167   

 

F-18


Biota Holdings Limited.

Notes to Consolidated Financial Statements (Unaudited)

(for the quarters ended September 30, 2011 and 2012)

 

Reconciliation of EBITDA to reported loss from continuing operations

 

     Quarter ended September 30,  
     2012
US$’000
    2011
US$’000
 

EBITDA

     (7,081     (4,276

Interest revenue

     537        985   

Depreciation

     (445     (428

Amortisation

     (169     (255

Share expenses

     (183     (353
  

 

 

   

 

 

 

Loss before income tax from continuing operations

     (7,341     (4,327
  

 

 

   

 

 

 

 

(8) Events subsequent to balance date

Merger with Nabi

On 9 November 2012, the Company completed the merger with Nabi Biopharmaceuticals, Inc (Nabi). As a result Biota Holdings Limited delisted from the Australian Stock Exchange (ASX:BTA) and listed on NASDAQ as Biota Pharmaceuticals, Inc. (NASDAQ:BOTA).

On merger, former Biota Holdings Limited shareholders retained approximately 83% of the combined entity, while former Nabi shareholders retained approximately 17% of Biota Pharmaceuticals, Inc. in return for the US$27 million cash that was the sole asset of Nabi on the date of the transaction. Nabi’s main product NicVAX® suffered a significant setback in 2011 when it did not achieve the primary endpoint in two Phase III efficacy trials. Given this, the combined company’s operations going forward will be materially represented by the Biota operations.

The merger will be accounted for as a ‘reverse merger’ and Biota Holdings Limited is the accounting acquirer with Nabi Biopharmaceuticals being treated as the acquired company for future financial reporting purposes, given that former Biota Holdings Limited shareholders hold a majority of the ongoing voting interest in Biota Pharmaceuticals Inc. In addition members of the new Board and management will be principally drawn from the Biota Holdings Limited business and the majority of the ongoing business will be related to Biota Holdings Limited business.

Total transaction costs incurred, or which are expected to be incurred, by Biota in relation to the implementation of the Merger are estimated at $6.3 million, including adviser, investment banking, legal, accounting and various other related costs. A number of these costs are contingent on the successful completion of the transaction and these costs will be recognised in the financial statements for the quarter ended December 31, 2012. During the quarter ended September 30, 2012, $1.3 million of these costs were expensed and cumulatively $3.2 million has been expensed to-date.

Collection of contingent asset

An application for a claim of $4.2 million was made by Biota under the Australian Government’s Research and Development tax incentive (‘Offset”) when Biota submitted its 2012 tax return. As this was the first year of the Offset, Biota viewed it is appropriate to understand how the offset will be administered by the Australian Taxation Office and AusIndustry before recognition in the financial statements and concluded that this amount represented a contingent asset at balance date. Biota subsequently received this claim on November 7, 2012 and will recognise this in the statement of operations in the quarter ending December 31, 2012.

 

F-19