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

FORM 10-Q

(Mark one)    

ý

 

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

For the quarterly period ended September 30, 2009

OR

o

 

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

For the transition period from                        to                         

Commission File Number: 0-15223

HEMACARE CORPORATION
(Exact name of registrant as specified in its charter)

California   95-3280412
(State or other jurisdiction
of incorporation or organization)
  (I.R.S. Employer
Identification No.)

15350 Sherman Way, Suite 350
Van Nuys, California

 

91406
(Address of principal executive offices)   (Zip Code)

(818) 226-1968
(Registrant's telephone number, including area code)

        Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ý    No o

        Indicate by check mark whether the registrant has submitted electronically and posted on its corporate web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes o    No o

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

Large Accelerated Filer o   Accelerated Filer o   Non-Accelerated Filer o
(Do not check if a smaller
reporting company)
  Smaller reporting company ý

        Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes o    No ý

        As of November 6, 2009, 10,049,539 shares of Common Stock of the registrant were issued and outstanding.


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HEMACARE CORPORATION

INDEX TO FORM 10-Q

FOR THE THREE AND NINE MONTHS ENDED
SEPTEMBER 30, 2009

 
   
  Page
Number
 

PART I

 

FINANCIAL INFORMATION

       

Item 1.

 

Financial Statements

       

 

Condensed Consolidated Balance Sheets as of September 30, 2009 (unaudited) and December 31, 2008

    1  

 

Condensed Consolidated Statements of Income for the three and nine months ended September 30, 2009 and 2008 (unaudited)

    2  

 

Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2009 and 2008 (unaudited)

    3  

 

Notes to Unaudited Condensed Consolidated Financial Statements

    4  

Item 2.

 

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

    16  

Item 3.

 

Quantitative and Qualitative Disclosures About Market Risk

    36  

Item 4T.

 

Controls and Procedures

    36  

PART II

 

OTHER INFORMATION

       

Item 1.

 

Legal Proceedings

    40  

Item 1A.

 

Risk Factors

    40  

Item 2.

 

Unregistered Sales of Equity Securities and Use of Proceeds

    42  

Item 3.

 

Defaults Upon Senior Securities

    42  

Item 4.

 

Submission of Matters to a Vote of Security Holders

    42  

Item 5.

 

Other Information

    42  

Item 6.

 

Exhibits

    42  

SIGNATURES

    43  

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PART I. FINANCIAL INFORMATION

Item 1.    Financial Statements

        


HEMACARE CORPORATION

CONDENSED CONSOLIDATED BALANCE SHEETS

 
  September 30,
2009
  December 31,
2008
 
 
  (unaudited)
   
 

Assets

             

Current assets:

             
 

Cash and cash equivalents

  $ 1,325,000   $ 903,000  
 

Accounts receivable, net of allowance for doubtful accounts of $167,000 in 2009 and $226,000 in 2008

    3,888,000     6,051,000  
 

Product inventories and supplies

    1,203,000     1,166,000  
 

Prepaid expenses

    666,000     704,000  
 

Assets held for sale

    319,000     319,000  
 

Other receivables

    81,000     58,000  
           
   

Total current assets

    7,482,000     9,201,000  

Plant and equipment, net of accumulated depreciation and amortization of $6,385,000 in 2009 and $5,650,000 in 2008

    4,207,000     4,417,000  

Other assets

    85,000     78,000  
           

Total assets

  $ 11,774,000   $ 13,696,000  
           

Liabilities and Shareholders' Equity

             

Current liabilities:

             
 

Accounts payable

  $ 1,917,000   $ 2,823,000  
 

Accrued payroll and payroll taxes

    1,083,000     784,000  
 

Other accrued expenses

    254,000     333,000  
 

Liabilities related to assets held for sale

    2,139,000     2,102,000  
 

Current obligation under notes payable

    416,000     2,471,000  
           
   

Total current liabilities

    5,809,000     8,513,000  
           

Deferred rent

    612,000     645,000  

Long-term obligation under notes payable

    47,000      
           

Shareholders' equity:

             
 

Common stock, no par value—20,000,000 shares authorized, 10,049,539 issued and outstanding in 2009 and 9,886,955 in 2008

    16,312,000     16,204,000  
 

Accumulated deficit

    (11,006,000 )   (11,666,000 )
           
   

Total shareholders' equity

    5,306,000     4,538,000  
           

Total liabilities and shareholders' equity

  $ 11,774,000   $ 13,696,000  
           

The accompanying notes are an integral part of these unaudited condensed
consolidated financial statements

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HEMACARE CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF INCOME

(UNAUDITED)

 
  Three Months Ended
September 30,
  Nine Months Ended
September 30,
 
 
  2009   2008   2009   2008  

Revenue

                         
 

Blood products

  $ 6,308,000   $ 7,573,000   $ 22,332,000   $ 21,632,000  
 

Blood services

    2,093,000     1,901,000     5,808,000     6,010,000  
                   
   

Total revenue

    8,401,000     9,474,000     28,140,000     27,642,000  

Operating costs and expenses

                         
 

Blood products

    5,467,000     6,487,000     18,862,000     18,517,000  
 

Blood services

    1,481,000     1,476,000     4,251,000     4,328,000  
                   
   

Total operating costs and expenses

    6,948,000     7,963,000     23,113,000     22,845,000  
   

Gross profit

    1,453,000     1,511,000     5,027,000     4,797,000  

General and administrative expenses

    1,295,000     1,452,000     4,368,000     4,375,000  
                   

Income from operations

    158,000     59,000     659,000     422,000  

Other income

        396,000         331,000  
                   

Income before income taxes

    158,000     455,000     659,000     753,000  

(Benefit from) provision for income taxes

    (88,000 )       (38,000 )   45,000  
                   

Income from continuing operations

    246,000     455,000     697,000     708,000  
                   

Discontinued Operations:

                         

(Loss) income from discontinued operations

    (13,000 )   (170,000 )   (37,000 )   92,000  
                   

Net income

  $ 233,000   $ 285,000   $ 660,000   $ 800,000  
                   

Income (loss) per share

                         

Basic

                         
 

Continuing operations

  $ 0.02   $ 0.05   $ 0.07   $ 0.08  
                   
 

Discontinued operations

  $   $ (0.02 ) $   $ 0.01  
                   
 

Total

  $ 0.02   $ 0.03   $ 0.07   $ 0.08  
                   

Diluted

                         
 

Continuing operations

  $ 0.02   $ 0.05   $ 0.07   $ 0.07  
                   
 

Discontinued operations

  $   $ (0.02 ) $   $ 0.01  
                   
 

Total

  $ 0.02   $ 0.03   $ 0.07   $ 0.08  
                   

Weighted average shares outstanding—basic

    10,050,000     9,696,000     9,994,000     9,415,000  
                   

Weighted average shares outstanding—diluted

    10,257,000     9,942,000     10,086,000     9,588,000  
                   

The accompanying notes are an integral part of these unaudited condensed
consolidated financial statements

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HEMACARE CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(UNAUDITED)

 
  For the Nine Months Ended
September 30,
 
 
  2009   2008  

Cash flows from operating activities:

             
 

Net income

  $ 660,000   $ 800,000  
 

Adjustments to reconcile net income to net cash provided by operating activities:

             
   

Loss (income) from discontinued operations

    37,000     (92,000 )
   

Recovery of bad debts

    (44,000 )   (72,000 )
   

Depreciation and amortization

    770,000     753,000  
   

Loss on disposal of assets

    3,000     3,000  
   

Share-based compensation

    108,000     97,000  
   

Gain on transfer of common stock

        (126,000 )
   

Discharge of debt and related accrued interest

        (242,000 )

Changes in operating assets and liabilities:

             
 

Decrease (increase) in accounts receivable

    2,207,000     (1,060,000 )
 

Decrease (increase) in inventories, supplies and prepaid expenses

    1,000     (337,000 )
 

(Increase) decrease in other receivables

    (23,000 )   24,000  
 

(Increase) decrease in other assets

    (7,000 )   6,000  
 

(Decrease) increase in accounts payable, accrued payroll, accrued expenses expenses and deferred rent

    (719,000 )   285,000  
           
 

Net cash provided by operating activities

    2,993,000     39,000  

Cash flows from investing activities:

             
 

Proceeds from the sale of plant and equipment

    8,000      
 

Purchases of plant and equipment

    (571,000 )   (451,000 )
           
 

Net cash used in investing activities

    (563,000 )   (451,000 )

Cash flows from financing activities:

             
 

Proceeds from sale of common stock

        433,000  
 

Proceeds from the exercise of stock options

        44,000  
 

Principal payments on notes payable

    (2,008,000 )   (426,000 )
           
 

Net cash (used in) provided by financing activities

    (2,008,000 )   51,000  
           

Net cash provided by (used in) continuing operations

    422,000     (361,000 )

Cash Flows—Discontinued Operations

             
 

Net cash provided by operating activities

        368,000  
           
 

Net cash provided by discontinued operations

        368,000  
           

Increase in cash and cash equivalents

    422,000     7,000  

Cash and cash equivalents at beginning of period

    1,215,000     556,000  
           

Cash and cash equivalents at end of period

    1,637,000     563,000  
           

Cash and cash equivalents—Continuing operations

    1,325,000     59,000  

Cash and cash equivalents—Assets held for sale

    312,000     504,000  
           
 

Total cash and cash equivalents

  $ 1,637,000   $ 563,000  
           

Supplemental disclosure:

             
 

Interest paid

  $ 112,000   $ 118,000  
           
 

Income taxes (refunded) paid

  $ (12,000 ) $ 22,000  
           

Supplemental disclosure of non-cash activities

             
 

Transfer of common stock due to settlement of litigation

      $ (126,000 )
           
 

Reduction in notes payable and related accrued interest due to settlement of litigation

      $ (242,000 )
           

The accompanying notes are an integral part of these unaudited condensed
consolidated financial statements

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HemaCare Corporation

Notes to Unaudited Condensed Consolidated Financial Statements

Note 1—Basis of Presentation and General Information

BASIS OF PRESENTATION

        In the opinion of management, the accompanying (a) condensed consolidated balance sheet as of December 31, 2008, which has been derived from audited financial statements, and (b) the unaudited interim condensed consolidated financial statements for the three and nine months ended September 30, 2009 and 2008, include all adjustments (consisting of normal recurring accruals) which management considers necessary to present fairly the financial position of the Company as of September 30, 2009 and December 31, 2008, the results of its operations for the three and nine months ended September 30, 2009 and 2008, and its cash flows for the nine months ended September 30, 2009 and 2008 in conformity with accounting principles generally accepted in the United States ("GAAP").

        These financial statements have been prepared consistently with the accounting policies described in the Company's Annual Report on Form 10-K for the year ended December 31, 2008, as filed with the Securities and Exchange Commission ("SEC") on March 26, 2009, which should be read in conjunction with this Quarterly Report on Form 10-Q. The notes from the consolidated financial statements for 2008 are incorporated by reference from the Notes to Consolidated Financial Statements as of December 31, 2008 as described in the Company's Annual Report on Form 10-K. The results of operations for the three and nine months ended September 30, 2009 are not necessarily indicative of the consolidated results of operations to be expected for the full fiscal year ending December 31, 2009. The above unaudited condensed consolidated financial statements have been prepared pursuant to the rules and regulations of the SEC. Certain information and note disclosures normally included in annual financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to those rules and regulations, although the Company believes that the disclosures made are adequate to make the information not misleading.

USE OF ESTIMATES

        The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, and disclosure of contingent assets and liabilities at the date of the financial statements. Estimates also affect the reported amounts of revenue and expenses during the reporting period. Actual results could differ from those estimates.

        Revenue and Accounts Receivable:    Revenue is recognized upon acceptance of the blood products or the performance of blood services. Occasionally the Company receives advance payment against future delivery of blood products or services. Until the related products or services are delivered, the Company records advance payments as deferred revenue, which appears as a current liability on the balance sheet. Blood services revenue consists primarily of mobile therapeutic procedure fees, while blood products revenue consists primarily of sales of single donor platelets, whole blood components or other blood products that are manufactured or purchased and distributed by the Company. Accounts receivable are reviewed periodically for collectability. The Company estimates an allowance for doubtful accounts based on balances owed that are 90 days or more past due from the invoice date, unless evidence exists, such as subsequent cash collections, that specific amounts are collectable. In addition, balances less than 90 days past due are reserved based on the Company's recent bad debt experience.

        Inventories and Supplies:    Inventories consist of Company-manufactured platelets, whole blood components and other blood products, as well as component blood products purchased for resale. Supplies consist primarily of medical supplies used to collect and manufacture products and to provide therapeutic services. Inventories are stated at the lower of cost or market and are accounted for on a

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first-in, first-out basis. Management estimates the portion of inventory that might not have future value by analyzing historical sales for the twelve months prior to any balance sheet date. For each inventory type, management establishes an obsolescence reserve equal to the value of inventory quantity in excess of twelve months of historical sales quantity, using the first-in, first-out inventory valuation methodology. The Company did not record any reserves for obsolete inventory for continuing operations or discontinued operations as of September 30, 2009 or as of December 31, 2008.

        Financial Instruments:    On January 1, 2009, the Company adopted all of the provisions of Financial Accounting Standards Board Accounting Standards Codification, ("ASC"). ASC Topic 820, Fair Value Measurements and Disclosures ("ASC 820") which provides guidance on how to measure assets and liabilities that use fair value. ASC 820 defines fair value, establishes a framework for measuring fair value in accordance with GAAP, and expands disclosures about fair value measurements. The full adoption of ASC 820 did not have a material impact on the Company's financial statements.

        Share-Based Compensation:    As per the ASC Topics 505 and 718, Equity and Stock Based Compensation, an entity shall account for share-based compensation transactions with employees in accordance with the fair-value-based method, that is, the cost of services received from employees in exchange for awards of share-based compensation generally shall be measured based on the grant-date fair value of the equity instruments issued or on the fair value of the liabilities incurred. The Company's assessment of the estimated fair value of share-based payments is impacted by the price of the Company's stock, as well as assumptions regarding a number of complex and subjective variables and the related tax impact. Management calculated fair value based on fair value of the stock at the date of issuance for restricted stock and restricted stock units. Management utilized the Black-Scholes model to estimate the fair value of share-based payments granted. Valuation techniques used for employee share options and similar instruments estimate the fair value of those instruments at a single point in time (for example, at the grant date). The assumptions used in a fair value measurement are based on expectations at the time the measurement is made, and those expectations reflect the information that is available at the time of measurement.

        The Black-Scholes valuation model was developed for use in estimating the fair value of traded options that have no vesting restrictions and are fully transferable. This model also requires the input of highly subjective assumptions including:

        In the future, management may elect to use different assumptions under the Black-Scholes valuation model or a different valuation model, which could result in a significantly different impact on earnings.

        The Company currently uses the 2006 Equity Incentive Plan ("2006 Plan"), approved by shareholders at the 2006 annual meeting, to grant stock options and other share-based payments. At the March 18, 2009 meeting of the Board of Directors, the non-employee directors were awarded, per the Company's director compensation policy, their 2009 annual stock option grants utilizing the closing stock price on March 18, 2009, the date of the meeting. Since this grant was intended as compensation for annual service, and since the vesting policy requires quarterly vesting of non-employee director options, the Company recorded $9,000 and $29,000 of share-based compensation for the three and nine months ended September 30, 2009, respectively, utilizing the Black-Scholes valuation model.

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        Income Taxes:    The process of preparing the financial statements requires management estimates of income taxes in each of the jurisdictions that the Company operates. This process involves estimating current tax exposure together with assessing temporary differences resulting from differing treatment of items for tax and accounting purposes. These differences result in deferred tax assets and liabilities, which are included in the balance sheet. As per the ASC Topic 740, Income Taxes, the Company utilizes an asset and liability approach that requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in the Company's financial statements or tax returns. Management must assess the likelihood that the deferred tax assets or liabilities will be realized for future periods, and to the extent management believes that realization is not likely, must establish a valuation allowance. To the extent a valuation allowance is created or adjusted in a period, the Company must include an expense or benefit within the tax provision in the statements of operations.

        Significant management judgment is required in determining the provision for income taxes, deferred tax assets and liabilities and any valuation allowance recorded against net deferred tax assets. It is possible that a selection of different input variables could produce a materially different estimate of the provision, asset, liability and valuation allowance.

        Based on management's analysis of the Company's recent performance, management determined that there was insufficient evidence of guaranteed future profitability to insure that the Company would realize any benefit from the deferred tax assets. Therefore, as of September 30, 2009, the Company continued to record a 100% valuation reserve against all of the deferred tax assets.

        In September 2008, the State of California suspended the use of net operating loss carryforwards when calculating income taxes for 2008 and 2009. Although the Company has generated income in the first nine months of 2009, management has determined that sufficient temporary book to tax differences exist that it is unlikely the Company will have any income tax liability to the State of California for 2009.

CONCENTRATION OF CREDIT RISK

        The Company maintains cash balances at various financial institutions. Deposits not exceeding $250,000 for each institution are insured by the Federal Deposit Insurance Corporation. At September 30, 2009, excluding cash included in assets held for sale, the Company had uninsured cash and cash equivalents of $979,000. On December 31, 2008, the Company's uninsured cash and cash equivalents were $712,000, excluding cash included in assets held for sale.

RECENT ACCOUNTING PRONOUNCEMENTS

        ASC Topic 320, Subtopic 10, InvestmentsDebt and Equity Securities—Overall, which addresses the former Financial Accounting Standards Board ("FASB") Staff Position ("FSP") No. Financial Accounting Standard ("FAS") 115-2 and FAS 124-2, Recognition and Presentation of Other-Than-Temporary Impairments, which amends the other-than-temporary impairment guidance for debt securities to make the guidance more operational and to improve the presentation and disclosure of other-than-temporary impairments on debt and equity securities. This ASC is effective for interim and annual periods ending after September 15, 2009. The implementation of this ASC did not have a material impact on the Company's consolidated financial statements.

        ASC Topic 820 Subtopic 10, Fair Value Measurements and Disclosures—Overall, ("ASC 820-10") Paragragh 65 relating to the former FSP No. FAS 157-4, Determining Fair Value When the Volume and Level of Activity for the Asset or Liability Have Significantly Decreased and Identifying Transactions That Are Not Orderly, issued in April, 2009 provides additional guidance for estimating fair value when the market activity for an asset or liability has declined significantly. This ASC is effective for interim and

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annual periods ending after September 15, 2009. The implementation of this did not have a material impact on the Company's consolidated financial statements.

        In May 2009, the FASB issued ASC Topic 855 Subtopic 10, Subsequent Events—Overall, formerly Statement of Financial Accounting Standard ("SFAS") No. 165, Subsequent Events. The standard does not require significant changes regarding recognition or disclosure of subsequent events, but does require disclosure of the date through which subsequent events have been evaluated for disclosure and recognition. The standard is effective for financial statements issued after September 15, 2009. The implementation of this standard did not have a material impact on the financial statements of the Company. Subsequent events through the filing date of this Quarterly Report on Form 10-Q have been evaluated for disclosure and recognition.

        In August 2009, the FASB issued Accounting Standards Update ("ASU") 2009-05, Fair Value Measurements and Disclosures—Measuring Liabilities at Fair Value ("ASU 2009-05"). The objective of ASU 2009-05 is to clarify how entities should estimate the fair value of liabilities under the ASC 820. ASU 2009-05 provides amendments to ASC 820-10, for the fair value measurement of liabilities. This ASU is effective for first reporting period, including interim periods, beginning after issuance. The implementation of this standard did not have a material impact on the financial statements of the Company.

        In September 2009, the FASB issued ASU 2009-12, Fair Value Measurements and Disclosures—Investments in Certain Entities That Calculate Net Asset Value per Share (or Its Equivalent) ("ASU 2009-12"). ASU 2009-12 provides amendments to ASC 820-10, for the fair value measurement of investments in certain entities that calculate net asset value per share (or its equivalent). The amendments in ASU 2009-12:

        The adoption of this standard has no impact on the Company's financial position, results of operation or cash flows.

        In September 2009, the FASB issued ASU 2009-01, The FASB Accounting Standards Codification and the Hierarchy of Generally Accepted Accounting Principles, a replacement of FASB Statement No. 162 ("ASU 2009-01"), formerly SFAS No. 162, which identifies the sources of accounting principles and the framework for selecting the principles used in the preparation of financial statements of nongovernmental entities that are presented in conformity with GAAP in the United States. This statement is effective for financial statements issued for interim and annual periods ending after September 15, 2009. The adoption of this standard will change how the Company references various elements of GAAP when preparing financial statement disclosures, but will have no impact on the Company's financial position, results of operation or cash flows.

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        In June 2009, the FASB issued SFAS No. 166, Accounting for Transfers of Financial Assets ("SFAS No. 166). SFAS No. 166 revises SFAS No. 140, Accounting for Transfers and Servicing of Financial Assets and Extinguishments of Debt, and enhances information reported to users of financial statements by providing greater transparency about transfers of financial assets, including securitization transactions, and where companies have continuing exposure to the risks related to transferred financial assets. SFAS No. 166 is effective as of the beginning of each reporting entity's first annual reporting period that begins after November 15, 2009, for interim periods within that first annual report and for interim and annual reporting periods thereafter. As of the date of the filing of this quarterly 10Q, SFAS No. 166 has not yet been added into the ASC. The adoption of this standard will have no impact on the Company's financial position, results of operations or cash flows.

Note 2—Inventory

        Inventories consist of Company-manufactured platelets, whole blood components and other blood products, as well as component blood products purchased for resale. Supplies consist primarily of medical supplies used to collect and manufacture products and to provide therapeutic services. Inventories are stated at the lower of cost or market and are accounted for on a first-in, first-out basis.

        Inventories are comprised of the following as of:

 
  September 30,
2009
  December 31,
2008
 

Supplies

  $ 699,000   $ 761,000  

Blood products

    504,000     405,000  
           

Total

  $ 1,203,000   $ 1,166,000  
           

Note 3—Discontinued Operations

        On November 5, 2007, the Board of Directors of the Company's wholly owned subsidiary, HemaCare BioScience, Inc. ("HemaBio"), in consultation with, and with the approval of, the Board of Directors of the Company, decided that it was in the best interest of HemaBio's creditors to close all operations of HemaBio. On December 4, 2007, HemaBio executed an Assignment for Benefit of Creditors, under Florida Statutes Section 727.101 et seq. ("Assignment"), assigning all of its assets to an assignee, who is responsible for taking possession of, protecting, preserving, and liquidating such assets and ultimately distributing the proceeds to creditors of HemaBio according to their priorities as established by Florida law. The assignee continues to fulfill his obligations under the Assignment, but has not concluded his efforts to liquidate all of the assets or complete a final distribution of all proceeds to HemaBio's creditors.

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        Per GAAP, the results of operations of HemaBio, along with an estimate of all closure related costs were recorded in 2007. The following is the breakdown of the assets held for sale and the liabilities related to the assets held for sale for the discontinued operations as of September 30, 2009 and December 31, 2008:


HEMACARE BIOSCIENCE, INC

Discontinued Operations

 
  September 30,
2009
  December 31,
2008
 
 
  (Unaudited)
   
 

Assets held for sale:

             

Cash and cash equivalents

  $ 312,000   $ 312,000  

Other receivables

    7,000     7,000  
           
 

Total assets held for sale

  $ 319,000   $ 319,000  
           

Liabilities related to assets held for sale:

             

Accounts payable

  $ 838,000   $ 838,000  

Accrued payroll and payroll taxes

    603,000     603,000  

Other accrued expenses

    198,000     161,000  

Current obligations under notes payable

    500,000     500,000  
           
 

Total liabilities related to assets held for sale

  $ 2,139,000   $ 2,102,000  
           

        Per GAAP, an entity in some form of reorganization, such as the assignment for benefit of creditors action filed for HemaBio in Florida, shall not recognize any gain from the relief of any obligation until relief is ordered by the courts, or a settlement of creditors is finalized. Since complete conveyance of assets, final settlement with all creditors or court action granting HemaBio relief from any creditors' claims, has not been obtained, HemaBio's liabilities remain, and will remain, recorded at full value on the financial statements of the Company as "liabilities related to assets held for sale" until such conveyance, settlement or court action is complete.

Note 4—Line of Credit and Notes Payable

        Until April 10, 2008, the Company's senior secured credit facility was with Comerica Bank ("Comerica"). The Comerica credit facility was collateralized by substantially all of the Company's assets and required the maintenance of certain covenants. This facility provided that, in the event the Company failed to observe any such covenants, or permitted a default in any material agreement to which the Company was a party with third parties that results in an acceleration of any indebtedness, then an event of default would have occurred under the Comerica facility, and Comerica may, among other things, declare the Company's indebtedness to Comerica immediately due and payable. From September 30, 2007 until April 10, 2008, the Company was not in compliance with certain financial covenants in the Comerica facility, and Comerica did not provide a waiver of this violation as provided in the past.

        On April 10, 2008, the Company, together with the Company's subsidiary Coral Blood Services, Inc., entered into a Credit and Security Agreement ("Wells Agreement") with Wells Fargo Bank ("Wells Fargo") to provide a $4.75 million, revolving line of credit for working capital purposes, and a $250,000 capital expenditure line of credit. The Wells Agreement provides that the Company may borrow the lesser of 85% of eligible accounts receivables, or $4.75 million with respect to the revolving line of credit. The term of the Wells Agreement is three years. Interest on the working capital line of credit is payable monthly at a rate of the Wells Fargo prime rate minus 0.25%, and interest on the capital expenditure line of credit is payable monthly at the Wells Fargo prime rate. As of September 30,

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2009, the interest rate on the Wells Fargo working capital line of credit was 3.00% and the interest rate on the Wells Fargo capital expenditure line of credit was 3.25%. The Wells Agreement also requires minimum monthly interest of $14,000. In addition, as of September 30, 2009, the Company had utilized $385,000 of the Wells Fargo working capital line of credit and $78,000 of the capital expenditure line of credit. The Wells Agreement is collateralized by substantially all of the Company's assets and requires the maintenance of certain covenants that, among other things, require minimum levels of profitability and prohibit the payment of dividends. As of September 30, 2009, the Company was in compliance with all of the covenants in the Wells Agreement.

        Upon closing of the Wells Agreement, the Company used the available proceeds to pay in full the outstanding debt obligation to Comerica. In exchange, the Company and Comerica terminated the Comerica credit facility, and Comerica released the security interest in the Company's assets.

        As part of the consideration to acquire HemaBio, the Company issued a promissory note to both of the sellers. One note for $153,800 for the benefit of Joseph Mauro required four equal annual installments of $38,450, plus accrued interest, commencing August 29, 2007 until paid. This note paid interest at 5% annually, was secured by all of the assets of HemaBio, and was subordinate to Comerica. The second note for $46,200 for the benefit of Valentin Adia required four equal annual installments of $11,550, plus accrued interest, commencing August 29, 2007 until paid. This note paid interest at 5% annually, was also secured by all of the assets of HemaBio, and was subordinate to Comerica.

        The Company failed to pay the first installment due to Mr. Mauro on August 29, 2007 of $46,000, which included $8,000 in accrued interest. Under the terms of the promissory note between the Company and Mr. Mauro, if an event of default occurred, the interest rate on the outstanding obligation increased to 12%. The Company's failure to pay the first installment was an event of default that triggered an increase in the interest rate. Therefore, since August 29, 2007, and until the note was cancelled, the Company accrued interest expense on the outstanding balance of this note at an interest rate of 12%.

        The Company failed to pay the first installment due to Mr. Adia on August 29, 2007 of $15,000, which included $3,000 in accrued interest.

        Disputes arose between the Company and Messrs. Mauro and Adia pertaining to the Company's acquisition of HemaBio, and their management of HemaBio after the acquisition. The dispute led to the filing of a lawsuit against Messrs. Mauro and Adia in the Los Angeles Superior Court (Case No. LC082173) (the "Lawsuit").

        On August 26, 2008, the Company entered into a Settlement Agreement and Mutual General Release (the "Mauro/Adia Agreement") with Messrs. Mauro and Adia. The Mauro/Adia Agreement resolves the disputes, including those alleged in the Lawsuit. The Mauro/Adia Agreement provides for the mutual general release of all claims between the Company and Messrs. Mauro and Adia in exchange for (i) Messrs. Mauro and Adia's cancellation of promissory notes and accrued interest, received from the Company as part of the HemaBio acquisition consideration; (ii) return of 248,000 shares of the Company's common stock received by Messrs. Mauro and Adia as part of the HemaBio acquisition consideration; and (iii) payment by Messrs. Mauro and Adia of $50,000 to the Company.

        As a result of the cancellation of the promissory notes, and other consideration received by the Company from the Mauro/Adia Agreement, the Company recognized a gain of $396,000, which is reported on the Company's third quarter 2008 income statement as a component of other income.

        When the Company acquired HemaBio, two former HemaBio investors, Dr. Lawrence Feldman and Dr. Karen Raben, each held a $250,000 note from HemaBio. Both of these notes require four equal annual installments of $62,500, plus accrued interest, commencing August 29, 2007, until paid and pay interest at 7% annually, and are secured by all of the assets of HemaBio, and were subordinate to Comerica.

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        HemaBio failed to pay the first installments due to Drs. Feldman and Raben on August 29, 2007 of $160,000, which included $35,000 in accrued interest. Under the terms of the promissory notes between HemaBio and Drs. Feldman and Raben, failure to pay any of the scheduled payments when due causes the entire unpaid balance, including unpaid interest, to become immediately due and payable, and causes the stated interest rate on both notes to increase to 10% per annum. Therefore, since August 29, 2007, HemaBio, now shown as discontinued operations, recognized accrued interest expense on the outstanding balance on both notes at an interest rate of 10%, which totaled $13,000 and $37,000 for the three and nine months ended September 30, 2009.

        The foregoing descriptions of the notes, the Comerica credit facility and the Mauro/Adia Agreement are qualified in their entirety by the copies of those agreements filed as exhibits to the Company's Current Reports on Form 8-K filed with the SEC on September 5, 2006, September 29, 2006, March 28, 2007 and September 5, 2008.

        As of September 30, 2009, HemaBio's default on the notes to Drs. Feldman and Raben remains unresolved.

Note 5—Shareholders' Equity

        The Company recognizes share-based compensation expense as required by ASC Topics 505 and 718, Equity and Stock Based Compensation. The measurement objective for equity instruments awarded to employees is to estimate the grant-date fair value of the equity instruments that the entity is obligated to issue when employees have rendered the requisite service and satisfied any other conditions necessary to earn the right to benefit from the instruments. That estimate is based on the share price and other pertinent factors (at the grant date and is not remeasured in subsequent periods under the fair-value-based method. This topic requires that the cost resulting from all share-based payment transactions be recognized in the financial statements. This topic establishes fair value as the measurement objective in accounting for share-based payment arrangements and requires all entities to apply a fair-value-based measurement method in accounting for share-based payment transactions. For the three and nine months ended September 30, 2009, the Company recognized an increase of $25,000 and $108,000 in share-based compensation costs including $9,000 and $29,000 of share-based compensation for non-employee director options. See Note 1 of Notes to Consolidated Financial Statements.

        The following summarizes the activity of the Company's stock options for the nine months ended September 30, 2009:

 
  Shares   Weighted
Average
Exercise
Price
  Weighted
Average
Remaining
Contractual
Term
(Years)
 

Number of shares under option:

                   

Outstanding at January 1, 2009

    1,641,000   $ 1.23        

Granted

    165,000     0.32        

Exercised

               

Cancelled or expired

    (76,000 )   0.74        

Forfeited

               
                 

Outstanding at September 30, 2009

    1,730,000   $ 1.17     6.1  
               

Exercisable at September 30, 2009

    1,380,750   $ 1.29     5.5  
               

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        The following summarizes the activity of the Company's stock options that have not yet vested as of September 30, 2009:

 
  Shares   Weighted
Average
Fair Value
 

Nonvested at January 1, 2009

    328,000   $ 0.77  

Granted

    165,000     0.30  

Vested

    (143,750 )   0.61  

Forfeited

         
           

Nonvested at September 30, 2009

    349,250   $ 0.62  
           

        The following summarizes the activity of the Company's restricted stock units for the nine months ended September 30, 2009:

 
  Shares   Weighted
Average
Exercise Price
 

Restricted Stock Units:

             

Outstanding at January 1, 2009

    47,200   $ 0.00  

Granted

         

Exercised

    (47,200 )   0.00  

Cancelled or expired

         
           

Outstanding at September 30, 2009

         
           

Exercisable at September 30, 2009

         
           

        The following summarizes the activity of the Company's restricted stock for the nine months ended September 30, 2009:

 
  Shares   Weighted
Average
Exercise Price
 

Restricted Stock:

             

Outstanding at January 1, 2009

    115,385   $ 0.00  

Granted

         

Exercised

    (115,385 )   0.00  

Cancelled or expired

         
           

Outstanding at September 30, 2009

         
           

Exercisable at September 30, 2009

         
           

        As of September 30, 2009, there was $128,000 of total unrecognized compensation cost related to nonvested share-based compensation arrangements granted under existing share-based payments. This cost is expected to be recognized over a weighted-average period of 2.4 years. The total measurement fair value of shares vested during the nine months ended September 30, 2009 was $88,000.

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        The Black-Scholes option pricing model is used by the Company to determine the weighted average fair value of share-based payments. The fair value at date of grant and the assumptions utilized to determine such values are indicated in the following table:

 
  Three Months
Ended
September 30, 2009
  Nine Months
Ended
September 30, 2009
 

Weighted average fair value at date of grant for share-based payments awarded during the period

  $ 0.35   $ 0.30  

Weighted average fair value at date of grant for share-based payments vested during the period

    0.29     0.61  

Risk-free interest rates

    3.1 %   2.4 %

Expected stock price volatility

    156.4 %   157.0 %

Expected dividend yield

    0 %   0 %

Expected forfeitures

    29.5 %   14.7 %

        Starting in the first quarter of 2008, the Company no longer assumes a forfeiture rate when assessing value for options held by independent members of the Board of Directors. Since options issued to independent board members are not forfeited upon separation from the Company, management has determined it is inappropriate to assign a forfeiture rate to these options.

        The Company uses the 2006 Plan to encourage ownership in the Company by key personnel whose long-term service is considered essential to the Company's continued progress, thereby linking these employees directly to stockholder interests through increased stock ownership. A total of 1,200,000 shares of the Company's common stock have been reserved for issuance under the 2006 Plan. As of September 30, 2009, the Company had utilized 917,585 of the shares reserved under the 2006 Plan, and 282,415 shares remain available. Awards may be granted to any employee, director or consultant of the Company or its subsidiaries, or those of the Company's affiliates.

        Prior to the 2006 Plan, the Company utilized the 1996 Stock Incentive Plan ("1996 Plan"). The 1996 Plan expired on July 19, 2006, although options remain outstanding that were originally issued under this plan.

Note 6—Earnings per Share

        The following table provides the calculation methodology for the numerator and denominator for diluted earnings per share:

 
  For the Three Months Ended
September 30,
  For the Nine Months Ended
September 30,
 
 
  2009   2008   2009   2008  

Continuing Operations

                         
 

Net income

  $ 246,000   $ 455,000   $ 697,000   $ 708,000  
                   
 

Weighted average shares outstanding

    10,050,000     9,696,000     9,994,000     9,415,000  
 

Net effect of dilutive options and warrants

    207,000     246,000     92,000     173,000  
                   
 

Diluted shares outstanding

    10,257,000     9,942,000     10,086,000     9,588,000  
                   

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  For the Three Months Ended
September 30,
  For the Nine Months Ended
September 30,
 
 
  2009   2008   2009   2008  

Discontinued Operations

                         
 

Net (loss) income

  $ (13,000 ) $ (170,000 ) $ (37,000 ) $ 92,000  
                   
 

Weighted average shares outstanding

    10,050,000     9,696,000     9,994,000     9,415,000  
 

Net effect of dilutive options and warrants

    207,000     246,000     92,000     173,000  
                   
 

Diluted shares outstanding

    10,257,000     9,942,000     10,086,000     9,588,000  
                   

        Options outstanding representing 1,240,000 and 1,385,000 shares of common stock for the three and nine months ended September 30, 2009, respectively, have been excluded from the above calculation because their effect would have been anti-dilutive.

        Options and restricted stock units outstanding of 1,335,000 shares of common stock for the three and nine months ended September 30, 2008 have been excluded from the above calculation because their effect would have been anti-dilutive.

Note 7—Provision for Income Taxes

        The process of preparing the financial statements includes estimating income taxes in each of the jurisdictions that the Company operates. This process involves estimating actual current tax exposure together with assessing temporary differences resulting from differing treatment of items for tax and accounting purposes. These differences result in deferred tax assets and liabilities, which are included in the balance sheet. Per GAAP, the Company must utilize an asset and liability approach that requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in the Company's financial statements or tax returns. Management must assess the likelihood that the deferred tax assets or liabilities will be realized for future periods, and to the extent management believes that realization is not likely, must establish a valuation allowance. To the extent a valuation allowance is created or adjusted in a period, the Company must include an expense, or benefit, within the tax provision in the statements of operations. Significant management judgment is required to determine the provision for income taxes, deferred tax asset and liabilities and any valuation allowance recorded against net deferred tax assets.

        Based on management's analysis of the Company's recent performance, management determined that there was insufficient evidence of guaranteed future profitability to insure that the Company would realize any benefit from the deferred tax assets. Therefore, as of September 30, 2009, the Company continued to record a 100% valuation reserve against all of the deferred tax assets.

        In September 2008, the State of California suspended the use of net operating loss carryforwards when calculating income taxes for 2008 and 2009. Although the Company has generated income in the first nine months of 2009, management has determined that sufficient temporary book to tax differences exist that it is unlikely the Company will have any income tax liability to the State of California for 2009.

        The Company uses the fair value recognition provisions of ASC Topics 505 and 718, Equity and Stock Based Compensation, which creates temporary differences between GAAP based net income and tax based net income because the compensation deduction permitted under this section is not deductible for taxes. When option holders exercise their rights to purchase the Company's shares, the Company is entitled to take a tax deduction, eliminating the temporary difference created when the option rights vested. The Company recognized $108,000 in share-based compensation expense in the nine months ended September 30, 2009. As a result of the temporary difference created, the Company's deferred tax asset balance increased $27,000. The Company recalculated the valuation

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reserve to include the addition to the deferred tax asset which resulted in no net change in the deferred tax asset reported on the balance sheet.

Note 8—Business Segments

        HemaCare operates in two business segments as follows:

        There were no intersegment revenues for the three or nine month periods ended September 30, 2009.

Note 9—Commitments and Contingencies

        State and federal laws set forth anti-kickback and self-referral prohibitions and otherwise regulate financial relationships between blood banks and hospitals, physicians and other persons who refer business to them. While the Company believes its present operations comply with applicable regulations, there can be no assurance that future legislation or rule making, or the interpretation of existing laws and regulations, will not prohibit or adversely impact the delivery by HemaCare of its services and products.

        Healthcare reform is continuously under consideration by lawmakers, and it is not certain as to what changes may be made in the future regarding health care policies. However, policies regarding reimbursement, universal health insurance and managed competition may materially impact the Company's operations.

        The Company is party to various claims, actions and proceedings incidental to its normal business operations. The Company believes the outcome of such claims, actions and proceedings, individually and in the aggregate, will not have a material adverse effect on the business and financial condition of the Company.

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

        The information contained in this Form 10-Q is intended to update the information contained in the Company's Annual Report on Form 10-K for the year ended December 31, 2008 and presumes that readers have access to, and will have read, the "Management's Discussion and Analysis of Financial Condition and Results of Operations" and other information contained in such Form 10-K. The following discussion and analysis also of the Company's financial condition and results of operations should be read in conjunction with the Company's financial statements and the related notes provided under "Item 1—Financial Statements" above.

        The matters discussed in "Management's Discussion and Analysis of Financial Condition and Results of Operations" and elsewhere in this Quarterly Report on Form 10-Q that are not historical are forward-looking statements. These statements may also be identified by the use of words such as "anticipate," "believe," "continue," "estimate," "expect," "intend," "may," "project," "will" and similar expressions, as they relate to the Company, its management and its industry. Investors and prospective investors are cautioned that these forward-looking statements are not guarantees of future performance and involve risks and uncertainties. Actual results could differ materially from those described in this report because of numerous factors, many of which are beyond the Company's control. These factors include, without limitation, those described below under the heading "Risk Factors Affecting the Company." The Company does not undertake to update its forward-looking statements to reflect later events and circumstances or actual outcomes.

General

        HemaCare Corporation ("HemaCare" or the "Company") provides customized delivery of blood products and services. The Company collects, processes, purchases and distributes blood products to hospitals and research related organizations. The Company operates and manages donor centers and mobile donor vehicles to collect transfusable blood products from donors. In addition, the Company purchases blood products from other blood suppliers. The Company also provides blood related services, principally therapeutic apheresis procedures, stem cell collection and other blood treatments to patients with a variety of disorders. Blood related therapeutic services are usually provided to hospitals under contract as an outside purchased service.

        The Company has operated in Southern California since 1979. In 1998, the Company expanded operations to include portions of the eastern United States. In 2003, the Company reduced the number of geographic regions served as part of a restructuring plan to return the Company to profitability. From 2003 through 2006, the Company's earnings improved as a result of the successful implementation of this plan. In August 2006, the Company acquired Florida based Teragenix Corporation, subsequently renamed HemaCare BioScience, Inc. ("HemaBio"), which sourced, processed and distributed human biological specimens, manufactured quality control products and provided clinical trial management and support services. Due to ongoing losses, and the resignation of the senior managers at HemaBio, the Board of Directors of HemaBio, in consultation with, and with the approval of, the Board of Directors of the Company, closed all operations of HemaBio, effective November 5, 2007.

        The Company's current strategy is to focus on increasing the utilization of existing blood products capacity in those markets currently served through investment in new marketing campaigns and expanded and enhanced donor recruitment programs, and to expand the market potential for therapeutic apheresis services through physician education and other marketing efforts.

        Although most suppliers of transfusable blood products are organized as not-for-profit, tax-exempt organizations, all suppliers charge fees for blood products to cover their cost of operations. The Company believes that it is the only investor-owned and taxable organization operating as a transfusable blood supplier with significant operations in the U.S.

        The Company was incorporated in the state of California in 1978.

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Results of Operations

        The Company's continuing operations generated $8,401,000 in revenue for the three months ended September 30, 2009, compared to $9,474,000 in the same period of 2008, representing a decrease of $1,073,000, or 11%. Blood Products revenue decreased $1,265,000, or 17%, while Blood Services revenue increased $192,000, or 10%.

        Gross profit from continuing operations for the three months ended September 30, 2009 decreased $58,000, or 4%, to $1,453,000 compared to $1,511,000 for the same period of 2008. This decrease is comprised of a $245,000 decrease, or 23%, in gross profit for the Blood Products business segment, and a $187,000 increase, or 44%, in gross profit for the Blood Services business segment. The gross profit as a percentage of revenue increased to 17% in the third quarter of 2009 compared to 16% for the same period of 2008.

        General and administrative expenses decreased 11% to $1,295,000 for the third quarter of 2009 from $1,452,000 in the same period of 2008.

        The company reported income from operations of $158,000 for the third quarter of 2009 compared to $59,000 for the same quarter of 2008, an increase of $99,000 or 168%.

        The Company did not record any other income in the third quarter of 2009, although $396,000 was recorded in the same period of 2008 as a result of the settlement reached with the former owners of HemaBio.

        The Company recorded a $88,000 benefit from income taxes for the three month period ended September 30, 2009, whereas the Company recorded no tax provision for the same three month period of 2008.

        Income from continuing operations decreased $209,000, or 46%, to $246,000 in the third quarter of 2009, compared to $455,000 for the same period of 2008, which included a non-recurring gain of $396,000 reported as other income.

        Discontinued operations generated a loss of $13,000 in the third quarter of 2009 compared to a loss of $170,000 in the third quarter of 2008.

        Net income for the three months ended September 30, 2009 decreased $52,000, or 18%, to $233,000 compared to $285,000 for the same period of 2008, which included a non-recurring gain of $396,000 reported as other income for the three months ended September 30, 2008.

        For this business segment, the following table summarizes the revenue and gross profit for the three months ended September 30, 2009 and 2008:


Blood Products

For the Three Months Ended September 30,

 
  2009   2008   Variance $   Variance %  

Revenue

  $ 6,308,000   $ 7,573,000   $ (1,265,000 )   (17 )%

Gross Profit

    841,000     1,086,000     (245,000 )   (23 )%

Gross Profit %

    13 %   14 %            

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        The 17% decrease in revenue as well as the 23% decrease in gross profit is primarily attributable to a decrease in customer demand for the Company's red cell products. The supply of blood products in the United States has increased significantly over the past year due to the overall deterioration of economic conditions. Increasing unemployment, and reduced confidence in economic stability by those who are employed, has caused many to delay healthcare decisions until economic conditions improve. The blood products industry has not completely adjusted production in response to the decrease in demand. This situation has created an unprecedented surplus of supply in the United States. As a result, competition amongst blood product suppliers for market share has intensified.

        In those markets where the Company operates, competitors have engaged in aggressive campaigns to encourage the Company's customers to purchase product. Using substantial price reductions and volume commitments, the competition has succeeded in capturing several customers previously served by the Company. Most notably, the Company has become the secondary supplier of blood products to the County of Los Angeles, which previously was the Company's largest single customer.

        The Company has responded by re-engaging with customers by offering customized value added programs, and communicating these programs clearly so the customer recognizes the economic advantage of partnering with the Company. As a result, the Company has succeeded in retaining customers that were targeted for conversion by the competition, and has attracted new customers as well.

        Most of the reduction in revenue has been from reduced sales of purchased products that the Company acquires from other suppliers for resale to its customers. As customer demand decreased, the Company reduced the purchases of purchased products, relying mostly on the Company's own collected product to satisfy customer demand.

        The decrease in gross profit percentage from 14% to 13% is primarily the result of a reduction in efficiency due to a reduction in utilization of the Company's blood collection and distribution capacity as sales volume declines.

        For the Blood Services business segment, the revenue and gross profit for the three months ended September 30, 2009 and 2008 is summarized on the following table:


Blood Services

For the Three Months Ended September 30,

 
  2009   2008   Variance $   Variance %  

Revenue

  $ 2,093,000   $ 1,901,000   $ 192,000     10 %

Gross Profit

  $ 612,000   $ 425,000   $ 187,000     44 %

Gross Profit %

    29 %   22 %            

        The 10% increase in revenue is primarily due to a 35% increase in the number of procedures performed in the Company's California market. This increase is the result of the Company successfully implementing a strategy to improve service quality and communicating its value proposition to customers. Revenue per procedure remained static compared to the same period of 2008.

        The 44% increase in gross profit percentage is due to a change in procedure mix to higher margin procedures, and efficiencies derived from greater utilization of the Company's service capacity.

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        General and administrative expenses for the three months ended September 30, 2009 and 2008 are summarized on the following table:


G&A Expenses

For the Three Months Ended September 30,

2009   2008   Variance $   Variance %  
$ 1,295,000     1,452,000   $ (157,000 )   (11 )%

        The 11% decrease in general and administrative expenses in the quarter is the result of a decrease in personnel programs of $52,000, a decrease in outside services of $28,000, a decrease in share-based compensation expense of $25,000, a decrease in travel related expenses of $16,000 and a decrease in liability insurance expense of $13,000.

        The decrease in the personnel programs is due to a lower 401(k) match accrual this quarter as compared to the same quarter in 2008. The decrease in outside services is the result of a reduction in legal fees and accounting fees. Share-based compensation decreased as a result of the recognition of compensation expense in the first quarter of 2008 associated with restricted stock and restricted stock units granted in early 2008 that did not exist in the third quarter of 2009. Travel related expenses decreased due to a reduction in travel by the Company's Chief Executive Officer to the Company's Maine offices as a result of hiring a new Regional Director in late 2008. The Company's overall improvement in profitability and a reduction in claims resulted in the decrease in liability insurance expense.

        For the both the third quarter of 2009 and 2008, general and administrative expenses represented 15% of revenue.

        The Company's continuing operations generated $28,140,000 in revenue in the first nine months of 2009, compared to $27,642,000 in the same period of 2008, representing an increase of $498,000, or 2%. Blood Products revenue increased $700,000, or 3%, while Blood Services revenue decreased $202,000, or 3%.

        Gross profit from continuing operations in the first nine months of 2009 increased $230,000, or 5%, to $5,027,000 compared to $4,797,000 for the same period of 2008. This increase is comprised of a $355,000 increase, or 11%, in gross profit for the Blood Products business segment, and a $125,000 decrease, or 7%, in gross profit for the Blood Services business segment. The Company's overall gross profit percentage increased to 18% in the nine months ended September 30, 2009, from 17% during the same period in 2008.

        General and administrative expenses decreased $7,000, or relatively unchanged, from $4,375,000 in the first nine months of 2008, to $4,368,000 during the first nine months of 2009.

        The Company recorded $659,000 of income from operations for the nine months ended September 30, 2009, compared with $422,000 during the same period of 2008, an increase of $237,000, or 56%.

        The Company did not record any other income in the first nine months of 2009, although $331,000 was recorded in the same period of 2008 due primarily to a settlement of litigation with the former owners of HemaBio.

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        The Company recorded a $38,000 benefit from income taxes for the nine month period ended September 30, 2009, whereas the Company recorded $45,000 in the provision for the same nine month period of 2008.

        Income from continuing operations decreased $11,000, or 2%, to $697,000 in the first nine months of 2009 compared to $708,000 for the same period in 2008, which included a non-recurring gain of $331,000 reported as other income.

        Discontinued operations generated a loss of $37,000 in the first nine months of 2009, compared to income of $92,000 in the same period of 2008.

        Net income for the nine month period ended September 30, 2009 decreased $140,000, or 18%, to $660,000, compared to $800,000 for the same period of 2008, which included a non-recurring gain of $331,000 reported as other income.

        For this business segment, the following table summarizes the revenue and gross profit for the nine months ended September 30, 2009 and 2008:


Blood Products

For the Nine Months Ended September 30,

 
  2009   2008   Variance $   Variance %  

Revenue

  $ 22,332,000   $ 21,632,000   $ 700,000     3 %

Gross Profit

    3,470,000     3,115,000     355,000     11 %

Gross Profit %

    16 %   14 %            

        The 3% increase in revenue is primarily attributable to an increase in red cell sales volume early in 2009 and an increase in platelet sales volume for all of 2009. The improvement is primarily the result of enhanced sponsor recruitment and donor recruitment efforts, and expanded collections of autologous and directed blood products. A recent decline in customer demand for red cell products as a result of the declining economy has mostly impacted the Company's sales of purchased products.

        In those markets where the Company operates, competitors have engaged in aggressive campaigns to encourage the Company's customers to purchase product. Using substantial price reductions and volume commitments, the competition has succeeded in capturing several customers previously served by the Company. Most notably, the Company has become the secondary supplier of blood products to the County of Los Angeles, which previously was the Company's largest single customer.

        The Company has responded by re-engaging with customers by offering customized value added programs, and communicating these programs clearly so the customer recognizes the economic advantage of partnering with the Company. As a result, the Company has succeeded in retaining customers that were targeted for conversion by the competition, and has attracted new customers as well.

        The 11% increase in gross profit and the increase in gross profit percentage from 14% to 16% is primarily the result of improved efficiencies derived from the greater utilization of the Company's collection and distribution capacity for all of the first nine months of 2009.

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        For the Blood Services business segment, the revenue and gross profit for the nine months ended September 30, 2009 and 2008 is summarized on the following table:


Blood Services

For the Nine Months Ended September 30,

 
  2009   2008   Variance $   Variance %  

Revenue

  $ 5,808,000   $ 6,010,000   $ (202,000 )   (3 )%

Gross Profit

  $ 1,557,000   $ 1,682,000   $ (125,000 )   (7 )%

Gross Profit %

    27 %   28 %            

        The 3% decrease in revenue is primarily due a decrease of 6% in the number of procedures performed in the California region, although recently the Company successfully implemented a strategy to improve service quality and communicate its value proposition to customers. The number of procedures performed in the Mid-Atlantic region remained unchanged. Average revenue per procedure for this segment increased slightly compared to the prior year.

        The decrease in gross profit and gross profit percentage is primarily attributable to the increase in regulatory and other overhead expenses allocated to the Blood Services segment as a result of an increase in stem cell collection regulatory requirements.

        General and administrative expenses for the nine months ended September 30, 2009 and 2008 are summarized on the following table:


General & Administrative Expenses

For the Nine Months Ended September 30,

2009   2008   Variance $   Variance %  
$ 4,368,000   $ 4,375,000   $ (7,000 )   0 %

        General and administrative expenses remained relatively unchanged between the nine month periods ended September 30, 2009 and 2008. Expenses decreased by $123,000 for officer salaries, $64,000 for personnel programs, $59,000 for bad debt expense, and $50,000 for liability insurance expense. Offsetting these decreases in general and administrative expenses were increases in outside services of $179,000, management bonuses of $59,000, and bank service charges of $32,000.

        The decrease in officer salaries was the result of changes in executive management, specifically the appointment of John Doumitt as the Company's Chief Executive Officer in late 2008, who was an executive of the Company during the first nine months of 2008. Since his appointment, the Interim Chief Executive Officer, who was also employed for most of 2008, ceased to serve in that capacity. The decrease in personnel programs reflects the lower 401(k) match accrual in 2009 as management adjusts the match accrual to coincide with the Company's performance. The decrease in bad debt expense is the result of an improvement in the quality of the Company's receivables directly related to enhancements in the Company's collection efforts. The Company's overall improvement in profitability and a reduction in loss claims caused the decrease in liability insurance expense.

        Outside services increased in the first nine months of 2009 compared with the same period in 2008 due to an increase in consulting costs related to Sarbanes-Oxley compliance. Management bonuses increased as a result of the Management Incentive Plan ("MIP") introduced in 2009. Finally, bank

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service charges increased as a result of the change in banking relationships from Comerica to Wells Fargo in the second quarter of 2008.

        For the first nine months of 2009 and 2008, general and administrative expenses represented 16% of revenue.

        The Company recorded a $38,000 benefit from income taxes in the nine months ended September 30, 2009, compared to an income tax provision of $45,000 for the same period of 2008. The Company filed amended 2005 and 2006 tax returns for New York State and New York City that resulted a refund of $14,000. This amount was recorded as a benefit from income taxes in the three month period ended September 30, 2009. In addition, a reconciliation of the 2008 tax provision and the 2008 tax returns, filed in the 3rd quarter of 2009, determined that the 2008 income tax provision was $29,000 higher than necessary. These benefits offset the addition of $6,000 to the provision for all of 2009. Since the Company continues to benefit from net operating loss carryforwards for Federal income taxes, all of the provision represents various state and local taxes management estimates the Company will pay as a result of the profits earned in the first nine months of 2009. The Company recorded a 100% valuation reserve against its deferred tax assets as of September 30, 2009 and 2008 respectively.

        In September 2008, the State of California suspended the use of net operating loss carryforwards when calculating income taxes for 2008 and 2009. Although the Company has generated income in the first three and nine months of 2009, management has determined that sufficient temporary book to tax differences exist that it is unlikely the Company will have any income tax liability to the State of California for 2009.

        The Company uses the fair value recognition approach pertaining to share-based compensation transactions. This adoption creates temporary differences between GAAP based net income and tax based net income because the compensation deduction permitted under GAAP is not deductible for taxes. When option holders exercise their rights to purchase the Company's shares, the Company is entitled to take a tax deduction, eliminating the temporary difference created when the option rights vested. The Company recognized $108,000 in share-based compensation expense in the first nine months of 2009. As a result of the temporary difference created, the Company's deferred tax asset balance increased $27,000. The Company recalculated the valuation reserve to include the addition to the deferred tax asset which resulted in no net change in the deferred tax asset reported on the balance sheet.

        On November 5, 2007, the Board of Directors of the Company's wholly owned subsidiary, HemaCare BioScience, Inc. ("HemaBio"), in consultation with, and with the approval of, the Board of Directors of the Company, decided that it was in the best interest of HemaBio's creditors to close all operations of HemaBio. On December 4, 2007, HemaBio executed an Assignment for Benefit of Creditors, under Florida Statutes Section 727.101 et seq. ("Assignment"), assigning all of its assets to an assignee, who is responsible for taking possession of, protecting, preserving, and liquidating such assets and ultimately distributing the proceeds to creditors of HemaBio according to their priorities as established by Florida law. The assignee continues to fulfill his obligations under the Assignment, but has not concluded his efforts to liquidate all of the assets or complete a final distribution of all proceeds to HemaBio's creditors.

Off-Balance Sheet Arrangements

        At September 30, 2009, the Company did not have any relationships with unconsolidated entities or financial partnerships, such as entities often referred to as structured finance, variable interest or

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special purpose entities, which would have been established for the purpose of facilitating off-balance sheet arrangements or other contractually narrow or limited purposes. As such, the Company is not exposed to any financing, liquidity, market or credit risk that could arise if it had engaged in such relationships.

Critical Accounting Policies and Estimates

        The Company's discussion and analysis of its financial condition and results of operations are based on the Company's consolidated financial statements, which have been prepared in accordance with GAAP. The preparation of these financial statements requires the Company to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities. On an on-going basis, the Company evaluates its estimates, including those related to valuation reserves, income taxes and intangibles. The Company bases its estimates on historical experience and on various other assumptions that management believes are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

        Share-Based Compensation:    ASC Topics 505 and 718, Equity and Stock Based Compensation, state that an entity shall account for the compensation cost from share-based payment transactions with employees in accordance with the fair-value-based method, that is, the cost of services received from employees in exchange for awards of share-based compensation generally shall be measured based on the grant-date fair value of the equity instruments issued or on the fair value of the liabilities incurred. The Company's assessment of the estimated fair value of share-based payments is impacted by the price of the Company's stock, as well as assumptions regarding a number of complex and subjective variables and the related tax impact. Management calculated fair value based on fair value of the stock at the date of issuance for restricted stock and restricted stock units. Management utilized the Black-Scholes model to estimate the fair value of share-based payments granted. Valuation techniques used for employee share options and similar instruments estimate the fair value of those instruments at a single point in time (for example, at the grant date). The assumptions used in a fair value measurement are based on expectations at the time the measurement is made, and those expectations reflect the information that is available at the time of measurement.

        The Black-Scholes valuation model was developed for use in estimating the fair value of traded options that have no vesting restrictions and are fully transferable. This model also requires the input of highly subjective assumptions including:

        In the future, management may elect to use different assumptions under the Black-Scholes valuation model or a different valuation model, which could result in a significantly different impact on earnings.

        Starting in the first quarter of 2008, the Company no longer assumed a forfeiture rate when assessing value for options held by independent members of the Board of Directors. Since options

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issued to independent board members are not forfeited upon separation from the Company, management determined it was inappropriate to assign a forfeiture rate to these options.

        In the future, management may elect to use different assumptions under the Black-Scholes valuation model or a different valuation model, which could result in a significantly different impact on net income or loss.

        The Company makes ongoing estimates relating to the collectibility of accounts receivable and maintains a reserve for estimated losses resulting from the inability of customers to meet their financial obligations to the Company. In determining the amount of the reserve, management considers the historical level of credit losses and makes judgments about the creditworthiness of significant customers based on ongoing credit evaluations. Since management cannot predict future changes in the financial stability of customers, actual future losses from uncollectible accounts may differ from the estimates. If the financial condition of customers were to deteriorate, resulting in their inability to make payments, a larger reserve may be required. In the event it was determined that a smaller or larger reserve was appropriate, the Company would record a credit or a charge to general and administrative expense in the period in which such a determination was made.

        Inventories consist of Company-manufactured platelets, whole blood components and other blood products, as well as component blood products purchased for resale. Supplies consist primarily of medical supplies used to collect and manufacture products and to provide therapeutic services. Inventories are stated at the lower of cost or market and are accounted for on a first-in, first-out basis. Management estimates the portion of inventory that might not have future value by analyzing historical sales history for the twelve months prior to any balance sheet date. For each inventory type, management establishes an obsolescence reserve equal to the value of inventory quantity in excess of twelve months of historical sales quantity, using the first-in, first-out inventory valuation methodology.

        As part of the process of preparing the financial statements, the Company is required to estimate income taxes in each of the jurisdictions that the Company operates. This process involves estimating actual current tax exposure together with assessing temporary differences resulting from differing treatment of items for tax and accounting purposes. These differences result in deferred tax assets and liabilities, which are included in the balance sheet. Management must then assess the likelihood that the deferred tax assets will be recovered from future taxable income, and to the extent management believes that recovery is not likely, must establish a valuation allowance. To the extent a valuation allowance is created or adjusted in a period, the Company must include an expense, or benefit, within the tax provision in the statements of income.

        Significant management judgment is required in determining the provision for income taxes, deferred tax assets and liabilities and any valuation allowance recorded against deferred tax assets. Management continually evaluates whether or not the deferred tax asset is likely to be realized. If management determines that the deferred tax asset is not likely to be realized, a write-down of that asset would be required and would be reflected in the provision for taxes in the accompanying period.

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Liquidity and Capital Resources

        The Company's primary sources of liquidity include cash on hand, available borrowings under the Wells Fargo line of credit, and cash generated from operations. Liquidity depends, in part, on timely collections of accounts receivable. Any significant delays in customer payments could adversely affect the Company's liquidity. Liquidity also depends on maintaining compliance with the various loan covenants.

        As of September 30, 2009, the Company's cash and cash equivalents for continuing operations were $1,325,000, and the Company's working capital for continuing operations was $3,493,000.

        Until April 10, 2008, the Company's senior secured credit facility was with Comerica Bank ("Comerica"). The Comerica credit facility was collateralized by substantially all of the Company's assets and required the maintenance of certain covenants. This facility provided that, in the event the Company failed to observe any such covenants, or permitted a default in any material agreement to which the Company was a party with third parties that results in an acceleration of any indebtedness, then an event of default would have occurred under the Comerica facility, and Comerica may, among other things, declare the Company's indebtedness to Comerica immediately due and payable. From September 30, 2007 and until April 10, 2008, the Company was not in compliance with certain financial covenants in the Comerica facility, and Comerica did not provide a waiver of this violation as provided in the past.

        On April 10, 2008, the Company, together with the Company's subsidiary Coral Blood Services, Inc., entered into a Credit and Security Agreement ("Wells Agreement") with Wells Fargo Bank ("Wells Fargo") to provide a $4.75 million, revolving line of credit for working capital purposes, and a $250,000 capital expenditure line of credit. The Wells Agreement provides that the Company may borrow the lesser of 85% of eligible accounts receivables, or $4.75 million with respect to the revolving line of credit. The term of the Wells Agreement is three years. Interest on the working capital line of credit is payable monthly at a rate of the Wells Fargo prime rate minus 0.25%, and interest on the capital expenditure line of credit is payable monthly at the Wells Fargo prime rate. As of September 30, 2009, the interest rate on the Wells Fargo working capital line of credit was 3.00% and the interest rate on the Wells Fargo capital expenditure line of credit was 3.25%. The Wells Agreement also requires minimum monthly interest payments of $14,000. In addition, as of September 30, 2009, the Company had utilized $385,000 of the Wells Fargo working capital line of credit and $78,000 of the capital expenditure line of credit. The Wells Agreement is collateralized by substantially all of the Company's assets and requires the maintenance of certain covenants that, among other things, require minimum levels of profitability and prohibit the payment of dividends. As of September 30, 2009, the Company was in compliance with all of the covenants in the Wells Agreement.

        Upon closing of the Wells Agreement, the Company used the available proceeds to pay in full off the outstanding debt obligation to Comerica in full. In exchange, the Company and Comerica terminated the Comerica credit facility, and Comerica released the security interest in the Company's assets.

        As part of the consideration to acquire HemaBio, the Company issued a promissory note to both of the sellers. One note for $153,800 for the benefit of Joseph Mauro required four equal annual installments of $38,450, plus accrued interest, commencing August 29, 2007 until paid. This note paid interest at 5% annually, and was secured through a security agreement, by all of the assets of HemaBio, and was subordinate to Comerica. The second note for $46,200 for the benefit of Valentin Adia, required four equal annual installments of $11,550, plus accrued interest, commencing August 29, 2007 until paid. This note paid interest at 5% annually, was also secured by all of the assets of HemaBio, and was subordinate to Comerica.

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        The Company failed to pay the first installment due to Mr. Mauro on August 29, 2007 of $46,000, which included $8,000 in accrued interest. Under the terms of the promissory note between the Company and Mr. Mauro, if an event of default occurred, the interest rate on the outstanding obligation increased to 12%. The Company's failure to pay the first installment was an event of default that triggered an increase in the interest rate. Therefore, since August 29, 2007, and until the note was cancelled, the Company accrued interest expense on the outstanding balance of this note at an interest rate of 12%.

        The Company failed to pay the first installment due to Mr. Adia on August 29, 2007 of $15,000, which included $3,000 in accrued interest.

        Disputes arose between the Company and Messrs. Mauro and Adia pertaining to the Company's acquisition of HemaBio, and their management of HemaBio after the acquisition. The dispute led to the filing of a lawsuit against Mauro and Adia in the Los Angeles Superior Court (Case No. LC082173) (the "Lawsuit").

        On August 26, 2008, the Company entered into a Settlement Agreement and Mutual General Release (the "Mauro/Adia Agreement") with Messrs. Mauro and Adia. The Mauro/Adia Agreement resolves the disputes, including those alleged in the Lawsuit. The Mauro/Adia Agreement provides for the mutual general release of all claims between the Company and Messrs. Mauro and Adia in exchange for (i) Messrs. Mauro and Adia's cancellation of promissory notes and accrued interest, received from the Company as part of the HemaBio acquisition consideration; (ii) return of 248,000 shares of the Company's common stock received by Messrs. Mauro and Adia as part of the HemaBio acquisition consideration; and (iii) payment by Messrs. Mauro and Adia of $50,000 to the Company.

        As a result of the cancellation of the promissory notes, and other consideration received by the Company from the Mauro/Adia Agreement, the Company recognized a gain of $396,000, which is reported on the Company's third quarter 2008 income statement as a component of other income.

        When the Company acquired HemaBio, two former HemaBio investors, Dr. Lawrence Feldman and Dr. Karen Raben, each held a $250,000 note from HemaBio. Both of these notes require four equal annual installments of $62,500, plus accrued interest, commencing August 29, 2007, until paid and pay interest at 7% annually, and are secured by all of the assets of HemaBio, and were subordinate to Comerica.

        HemaBio failed to pay the first installments due to Drs. Feldman and Raben on August 29, 2007 of $160,000, which included $35,000 in accrued interest. Under the terms of the promissory notes between HemaBio and Drs. Feldman and Raben, failure to pay any of the scheduled payments when due causes the entire unpaid balance, including unpaid interest, to become immediately due and payable, and causes the stated interest rate on both notes to increase to 10% per annum. Therefore, since August 29, 2007, HemaBio, now shown as discontinued operations, recognized accrued interest expense on the outstanding balance on both notes at an interest rate of 10%, which totaled $13,000 and $37,000 for the three and nine months ended September 30, 2009.

        The foregoing descriptions of the notes, the Comerica credit facility and the Mauro/Adia Agreement are qualified in their entirety by the copies of those agreements filed as exhibits to the Company's Current Reports on Form 8-K filed with the SEC on September 5, 2006, September 29, 2006, March 28, 2007 and September 5, 2008.

        As of September 30, 2009, HemaBio's default on the notes to Drs. Feldman and Raben remains unresolved.

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        Future minimum payments, including amounts in discontinued operations, under operating leases and notes payable are as follows:

 
  Total   Less than 1
Year
  1 - 3 Years   3 - 5 Years   More than 5
Years
 

Operating leases

  $ 5,129,000   $ 208,000   $ 1,662,000   $ 1,233,000   $ 2,026,000  

Notes Payable

    963,000     893,000     62,000     8,000      
                       

Totals

  $ 6,092,000   $ 1,101,000   $ 1,724,000   $ 1,241,000   $ 2,026,000  
                       

        For the nine months ended on September 30, 2009, cash provided by operating activities was $2,993,000, compared to $39,000 for the nine months ended September 30, 2008. The increase of $2,954,000 in cash provided between the two periods is primarily due to a decrease in accounts receivable of $2,207,000 compared with a $1,060,000 increase for the same period of 2008. HemaCare's days sales outstanding stood at 43 days as of September 30, 2009, compared to 56 days as of December 31, 2008. Management's focus on collections and monitoring the financial health of the Company's customers, contributed to this improvement during the first nine months of 2009. A decrease in inventories, supplies and prepaid expenses of $1,000 in the period, compared to an increase of $337,000 in the same period of 2008, along with a decrease in accounts payable, accrued expenses and other liabilities of $719,000 in the first nine months of 2009, compared to an increase of $285,000 in the same period of 2008, are additional components of the increase in cash provided by operating activities in the first nine months of 2009.

        For the nine months ended September 30, 2009, net cash used in investing activities was $563,000, compared to $451,000 for the same period in 2008. The difference of $112,000 is due to purchases of blood collection equipment and investments to implement the Company's information technology project.

        For the nine months ended September 30, 2009, net cash used in financing activities was $2,008,000, compared to net cash provided of $51,000 for the same period of 2008. The increase in cash used of $2,059,000 was due in part to the Company paying down $2,008,000 of the senior secured line of credit in the first nine months of 2009, compared with $426,000 during the first nine months of 2008. Additionally, the Company received proceeds from the sale of common stock to officers and directors in the amount of $433,000 in the first nine months of 2008 which did not occur in the first nine months of 2009.

        For discontinued operations, there was no change in cash during the first nine months of 2009, compared with $368,000 provided by operating activities in the same period of 2008, when many of HemaBio's assets were liquidated.

        Management anticipates that cash on hand, availability on the Wells Fargo bank line of credit and cash generated by operations will be sufficient to provide funding for the Company's needs during the next year, including working capital requirements, equipment purchases and operating lease commitments.

        The Company's primary sources of liquidity include cash on hand, available borrowing under the Wells Fargo line of credit, and cash generated from operations. Liquidity depends, in part, on timely collections of accounts receivable. Any significant delays in customer payments could adversely affect the Company's liquidity. Liquidity also depends on maintaining compliance with the various loan covenants. Presently, HemaBio is in default on two notes related to the HemaBio acquisition. See Note 4 of Notes to Consolidated Financial Statements.

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Risk Factors Affecting the Company

        The Company's short and long-term success is subject to many factors that are beyond management's control. Shareholders and prospective shareholders of the Company should consider carefully the following risk factors, in addition to other information contained in this report. The matters discussed in "Management's Discussion and Analysis of Financial Condition and Results of Operations" and elsewhere in this Quarterly Report on Form 10-Q that are not historical are forward-looking statements. These statements may also be identified by the use of words such as "anticipate," "believe," "continue," "estimate," "expect," "intend," "may," "project," "will" and similar expressions, as they relate to the Company, its management and its industry. Investors and prospective investors are cautioned that these forward-looking statements are not guarantees of future performance and involve risks and uncertainties, many of which will be beyond the control of the Company. Actual results could differ materially from those anticipated in these forward-looking statements as a result of various risks and uncertainties, including those discussed below or in other filings by the Company with the Securities and Exchange Commission. The Company does not undertake to update its forward-looking statements to reflect later events and circumstances or actual outcomes.

Changes in demand for blood products could affect profitability

        The Company's operations are structured to produce particular blood products based on customers' existing demand, and perceived potential changes in demand, for these products. Sudden or unexpected changes in demand for these products could have an adverse impact on the Company's profitability. Increasing demand could harm relationships with customers if the Company is unable to alter production capacity, or purchase products from other suppliers, to fill orders adequately. This could result in a decrease in overall revenue and profits. Decreases in demand may require the Company to make sizeable investments to restructure operations away from declining products to the production of new products. Lack of access to sufficient capital, or lack of adequate time to properly respond to such a change in demand, could result in declining revenue and profits as customers transfer to other suppliers. Additionally, an increase in the supply of blood products in the marketplace could result in declining revenue and profits for the Company due to a market driven decrease in prices.

Costs increasing more rapidly than market prices could reduce profitability

        The cost of collecting, processing and testing blood products has risen significantly in recent years and will likely continue to increase. These cost increases are related to new and improved testing procedures, increased regulatory requirements related to blood safety, and higher staff and supply costs related to collecting and processing blood products. Competition and fixed price contracts may limit the Company's ability to maintain existing operating margins. Some competitors have greater resources than the Company to sustain periods of marginally profitable or unprofitable sales. Costs increasing more rapidly than market prices, may reduce profitability and may have a material adverse impact on the Company's business and results of operations.

Competition may cause a loss of customers and an inability to pass on increases in costs thereby impacting profitability

        Competition in the blood products and blood services industries is primarily based on fees charged to customers. The Company's primary competition in the blood products market is the American Red Cross ("ARC"), which owns a significant market share advantage over the Company in the regions the Company operates. As a result, the ARC possesses significant market power to influence prices, which can prevent the Company from passing along increases in costs to customers. In addition, hospital consolidations and affiliations allow certain customers to negotiate as a group, exerting greater price pressure on the Company. These changes may have a negative impact on the Company's future revenue, and may negatively impact future profitability.

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Changing economic conditions could impact the ability of customers to pay the Company's invoices

        The Company's principal customers are hospitals that depend on payments from private insurance companies and governments to fund operations, and to pay the Company's invoices for products and services. Deteriorating economic conditions can result in higher unemployment and a related loss of medical insurance coverage for hospital patients. Reduced reimbursement for medical services can strain the financial health of the Company's hospital customers, which could impact the ability of these customers to pay the Company's invoices. The Company does not have sufficient resources to sustain operations for an extended period of time if any significant customer, or several smaller customers, failed to pay the Company's invoices as expected.

Declining blood donations could affect profitability

        The Company's blood products business depends on the availability of donated blood. Only a small percentage of the population donates blood, and regulations intended to reduce the risk of introducing infectious diseases in the blood supply, result in a decreased pool of potential donors. If the level of donor participation declines, the Company may not be able to reduce costs sufficiently to maintain profitability in blood products.

Operations depend on services of qualified professionals and competition for their services is strong

        The Company is highly dependent upon obtaining the services of qualified professionals. In particular, the Company's operations depend on the services of registered nurses, medical technologists, regulatory and quality assurance professionals, and others with knowledge of the blood industry. Nationwide, the demand for these professionals exceeds the supply and competition for their services is strong. The Company incurs significant costs to hire and retain staff. If the Company is unable to attract and retain a staff of qualified professionals, operations may be adversely affected which, in turn, may adversely impact profitability.

Industry regulations and standards could increase operating costs or result in closure of operations

        The business of collecting, processing and distributing blood products is subject to extensive and complex regulation by the state and federal governments. The Company is required to obtain and maintain numerous licenses in different legal jurisdictions regarding the safety, purity and quality of products, condition of facilities and that appropriate procedures are utilized. Periodically the FDA conducts inspections of HemaCare's facilities and operations. At the conclusion of each inspection, the FDA provides the Company with a list, if any, of observations of regulatory issues discovered during the inspection. On May 5, 2006, the Company received a warning letter from the FDA pertaining to specific observations from an inspection of the Company's California operations earlier that year. In August of 2007, the FDA performed another inspection of the Company's California operations. As a result of this inspection, the FDA provided the Company with a list of observations of regulatory issues, but took no further regulatory action. In July of 2009, the FDA performed another inspection of the Company's California operations. As a result of this inspection, the FDA provided the Company with a list of observations of regulatory issues, but none of the observations were repeat observations from previous inspections.

        The Company believes it has either adequately addressed the issues raised by the FDA, or is in the process of addressing these issues. The Company believes that its response and actions taken to address the FDA observations are sufficient that it is in compliance with current FDA regulations; however, the Company cannot insure against future FDA actions, including possible sanctions or closure of selected Company operations.

        On October 12, 2006, the AABB issued a timeline for gradual implementation of the United States Industry Consensus Standards for the Uniform Labeling of Blood and Blood Components using

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ISBT 128. To maintain accreditation, blood facilities would need to develop a written implementation plan by November 1, 2006 and complete full implementation by May 2008. The Company requested and received a variance from the AABB to delay the deadline for full implementation until December 31, 2008. In July 2009, the AABB announced that member organizations who fail to convert to ISBT 128 by November 1, 2009 will be subject to a change in their accreditation status to "conditional". The Company is in the process to convert to ISBT 128, but may not complete the conversion by the November 1, 2009 deadline. If so, the change in the Company's AABB accreditation status could impact the Company's relationship with selected customers who require blood suppliers to be AABB accredited.

        State and federal laws include anti-kickback and self-referral prohibitions and other regulations that affect the shipment of blood products and the relationships between blood banks, hospitals, physicians and other persons who refer business to each other. Health insurers and government payers, such as Medicare and Medicaid, also limit reimbursement for products and services, and require compliance with certain regulations before reimbursement will be made.

        The Company devotes substantial resources to complying with laws and regulations; however, the possibility cannot be eliminated that interpretations of existing laws and regulations will result in findings that the Company has not complied with existing regulations. Such a finding could materially harm the Company's business. Moreover, healthcare reform is continually under consideration by regulators, and the Company does not know how laws and regulations will change in the future.

Pandemic or epidemic outbreak of disease could significantly impact blood donations and have a material adverse impact on profitability

        If swine flu, avian flu, or other disease, were to develop into a worldwide pandemic, or epidemic in one or more of the regions in which the Company operates, the portion of the public that typically donates blood to the Company may be unable, or unwilling to donate, thereby significantly reducing the availability of blood that the Company relies upon to manufacture blood products. In addition, even if suspected diseases prove to be no more virulent than other more common disease, the heightened fear among the public resulting from widespread media coverage may result in dramatic decline in donations. Moreover, if a significant portion of the Company's workforce becomes ill, is required to stay home to care for ill family members, or is required to stay home in connection with social distancing programs intended to minimize disease transmission, the Company's operations could be significantly disrupted, which could have a material adverse impact on the Company's profitability.

Federal legislative proposals relating to the provision of health care may have a material effect on the Company

        There are complex legislative proposals pending in the United States Congress relating to health care insurance coverage, cost containment and payments. It is not possible at this time to evaluate whether there will be a material impact on the Company's operations or profitability from any final legislative enactments in this area, nor from any regulatory actions pursuant to any such legislation.

Decrease in reimbursement rates may affect profitability

        Reimbursement rates for blood products and services provided to Medicaid, Medicare and commercial patients, impact the fees that the Company is able to negotiate with customers. In addition, to the degree that the Company's hospital customers receive lower reimbursement for the products and services provided by the Company, these customers may reduce their demand for these goods and services, and adversely affect the Company's revenue. If the Company is unable to increase prices for goods and services, the Company's profitability may be adversely impacted.

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Not-for-profit status gives advantages to competitors

        HemaCare is the only significant blood products supplier to hospitals in the U.S. that is operated for profit and investor owned. The not-for-profit competition is exempt from federal and state taxes, and has substantial community support and access to tax-exempt financing. The Company may not be able to continue to compete successfully with not-for-profit organizations and the business and results of operations may suffer material adverse harm.

Discontinuation of the operations of the Company's Florida-based research subsidiary may hinder the Company's ability to generate profits

        The Company's Florida-based research subsidiary recorded a decrease in revenue and a related increase in operating losses throughout the first three quarters of 2007. On November 5, 2007, the Board of Directors of HemaBio closed this operation to avoid further losses. On December 4, 2007, HemaBio executed an Assignment for Benefit of Creditors, under Florida Statutes Section 727.101 et seq., assigning all of its assets to an assignee, who is responsible for taking possession of, protecting, preserving, and liquidating such assets and ultimately distributing the proceeds to creditors of HemaBio according to their priorities as established by Florida law. During 2008, the assignee successfully liquidated most of HemaBio's assets, including inventory, furniture and equipment. As of September 30, 2009, the assignee was still engaged to complete the liquidation and closure activities. These activities could temporarily increase costs, utilize scarce financial resources, distract management and have a material adverse impact on the Company and its results of operations. In addition, HemaBio creditors could attempt to pursue HemaCare for recovery of unpaid claims if they are not satisfied with the results of the Assignment for Benefit of Creditors process. If HemaBio's creditors are successful, HemaCare may not have sufficient liquidity to satisfy these obligations.

Potential inability to meet future capital needs could impact ability to operate

        The Company may not generate sufficient operating cash in the future to finance its operations for the next year. Currently, the Company is utilizing its credit facility with Wells Fargo to help finance its operations. The Company may need to raise additional capital in the debt or equity markets in order to finance future operations and procure necessary equipment. There can be no assurance that the Company will be able to obtain such financing on reasonable terms or at all. Additionally, there is no assurance that the Company will be able to obtain sufficient capital to finance future expansion.

Reliance on relatively few vendors for significant supplies and services could affect the Company's ability to operate

        The Company currently relies on a relatively small number of vendors to supply important supplies and services. Significant price increases, or disruptions in the ability to obtain products and services from existing vendors, may force the Company to find alternative vendors. Alternative vendors may not be available, or may not provide their products and services at favorable prices. If the Company cannot obtain the products and services it currently uses, or alternatives at reasonable prices, the Company's ability to produce products and provide services may be severely impacted, resulting in a reduction of revenue and profitability.

Potential adverse effect from changes in the healthcare industry, including consolidations, could affect access to customers

        Competition to gain patients on the basis of price, quality and service is intensifying among healthcare providers who are under pressure to decrease the costs of healthcare delivery. There has been significant consolidation among healthcare providers seeking to enhance efficiencies, and this consolidation is expected to continue. As a result of these trends, the Company may be limited in its

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ability to increase prices for products in the future, even if costs increase. Further, customer attrition as a result of consolidation or closure of hospital facilities may adversely impact the Company.

Future technological developments or alternative treatments could jeopardize the business

        As a result of the risks posed by blood-borne diseases, many companies and healthcare providers are currently seeking to develop alternative treatments for blood product transfusions. HemaCare's business consists of collecting, processing and distributing human blood products and providing blood related therapeutic services. The introduction and acceptance in the market of alternative treatments may cause material adverse harm to the future profitability for these products and to the Company's business.

Limited access to insurance could affect ability to defend against possible claims

        The Company currently maintains insurance coverage consistent with the industry; however, if the Company experiences losses or the risks associated with the blood industry increase in the future, insurance may become more expensive or unavailable. The Company also cannot give assurance that as the business expands, or the Company introduces new products and services, that additional liability insurance on acceptable terms will be available, or that the existing insurance will provide adequate coverage against any and all potential claims. Also, the limitations on liability contained in various agreements and contracts may not be enforceable and may not otherwise protect the Company from liability for damages. The successful assertion of one or more large claims against the Company that exceeds available insurance coverage, or changes in insurance policies, such as premium increases or the imposition of large deductibles or co-insurance requirements, may materially and adversely impact the Company's business.

Ability to attract, retain and motivate management and other skilled employees

        The Company's success depends significantly on the continued services of key management and skilled personnel. Competition for qualified personnel is intense and there are a limited number of people with knowledge of, and experience in, the blood product and blood service industries. The Company does not have employment agreements with most key employees, nor maintain life insurance policies on them. The loss of key personnel, especially without advance notice, or the Company's inability to hire or retain qualified personnel, could have a material adverse impact on revenue and on the Company's ability to maintain a competitive advantage. The Company cannot guarantee that it can retain key management and skilled personnel, or that it will be able to attract, assimilate and retain other highly qualified personnel in the future.

Product safety and product liability could provide exposure to claims and litigation

        Blood products carry the risk of transmitting infectious diseases, including, but not limited to, hepatitis, HIV and Creutzfeldt-Jakob disease. HemaCare screens donors, uses highly qualified testing service providers, and conducts selective blood testing, to test blood products for known pathogens in accordance with industry standards, and complies with all applicable safety regulations. Nevertheless, the risk that screening and testing processes might fail, or that new pathogens may be undetected by them, cannot be completely eliminated. There is currently no test to detect the pathogen responsible for Creutzfeldt-Jakob disease. If patients are infected by known or unknown pathogens, claims may exceed insurance coverage and materially and adversely impact the Company's financial condition.

Targeted partner blood drives involve higher collection costs

        Part of the Company's current operations involves conducting blood drives in partnership with hospitals. These blood drives are conducted under the name of the hospital partner and require that all

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promotional materials and other printed material include the name of the hospital partner. This strategy lacks the efficiencies associated with blood drives that are not targeted to benefit particular hospital partners. As a result, collection costs might be higher than those experienced by the Company's competition and may impact profitability and growth plans.

Environmental risks could cause the Company to incur substantial costs to maintain compliance

        HemaCare's operations involve the controlled use of bio-hazardous materials and chemicals. Although the Company believes that its safety procedures for handling and disposing of such materials comply with the standards prescribed by state and federal regulations, the risk of accidental contamination or injury from these materials cannot be completely eliminated. In the event of such an accident, the Company could be held liable for any damages that result, and any such liability could exceed the resources of the Company and its insurance coverage. The Company may incur substantial costs to maintain compliance with environmental regulations as it develops and expands its business.

Business interruption due to terrorism and increased security measures in response to terrorism could adversely impact profitability

        HemaCare's business depends on the free flow of products and services through the channels of commerce and freedom of movement for patients and donors. Delays or stoppages in the transportation of perishable blood products and interruptions of mail, financial or other services could have a material adverse impact on the Company's results of operations and financial condition. Furthermore, the Company may experience an increase in operating costs, such as costs for transportation, insurance and security, as a result of terrorist activities and potential activities, which may target health care facilities or medical products. The Company may also experience delays in receiving payments from payers that have been impacted by terrorist activities and potential activities. The U.S. economy in general is adversely impacted by terrorist activities, and potential activities, and any economic downturn may adversely impact the Company's results of operations, impair its ability to raise capital or otherwise adversely impact its ability to grow its business.

Business interruption due to earthquakes could adversely impact profitability

        HemaCare's principal blood products and blood services operations, as well as the Company's corporate headquarters, are located in Southern California, which is an area known for potentially destructive earthquakes. A severe event in this location could have a substantial negative impact on the ability of the Company to continue to operate. Any significant delay in resuming operations following such an event could cause a material adverse impact on the profitability of the Company. In addition, the Company's insurance policies do not provide any coverage for damages as a result of an earthquake. Therefore, the Company would bear all of the costs incurred to resume operations after an earthquake and the Company may not have sufficient resources to do so.

Evaluation and consideration of strategic alternatives, and other significant projects, may distract management from reacting appropriately to business challenges and lead to reduced profitability

        As a publicly traded Company, management must constantly evaluate and consider new strategic alternatives, and other significant projects, in an attempt to maximize shareholder value. The Company does not possess a large management team that can both consider strategic alternatives and manage daily operations. Therefore, management distractions associated with the evaluation and consideration of strategic alternatives could prevent management from dedicating appropriate time to immediate business challenges or other significant business decisions. This may cause a material adverse impact on the future profitability of the Company.

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Strategy to acquire companies may result in unsuitable acquisitions or failure to successfully integrate acquired companies, which could lead to reduced profitability

        The Company may embark on a growth strategy through acquisitions of companies or operations that complement existing product lines, customers or other capabilities. The Company may be unsuccessful in identifying suitable acquisition candidates, or may be unable to consummate a desired acquisition. To the extent any future acquisitions are completed, the Company may be unsuccessful in integrating acquired companies or their operations, or if integration is more difficult than anticipated, the Company may experience disruptions that could have a material adverse impact on future profitability. Some of the risks that may affect the Company's ability to integrate, or realize any anticipated benefits from, acquisitions include:

Articles of Incorporation and Rights Plan could delay or prevent an acquisition or sale of HemaCare

        HemaCare's Articles of Incorporation empower the Board of Directors to establish and issue a class of preferred stock, and to determine the rights, preferences and privileges of the preferred stock. This gives the Board of Directors the ability to deter, discourage or make more difficult for a change in control of HemaCare, even if such a change in control would be in the interest of a significant number of shareholders or if such a change in control would provide shareholders with a substantial premium for their shares over the then-prevailing market price for the Company's common stock.

        In addition, the Board of Directors has adopted a Shareholder's Rights Plan designed to require a person or group interested in acquiring a significant or controlling interest in HemaCare to negotiate with the Board. Under the terms of the Company's Shareholders' Rights Plan, in general, if a person or group acquires more than 15% of the outstanding shares of common stock, all of the other shareholders would have the right to purchase securities from the Company at a discount to the fair market value of the common stock, causing substantial dilution to the acquiring person or group. The Shareholders' Rights Plan may inhibit a change in control and, therefore, may materially adversely impact the shareholders' ability to realize a premium over the then-prevailing market price for the common stock in connection with such a transaction. For a description of the Shareholders' Rights Plan, see the Company's Current Report on Form 8-K filed with the SEC on March 20, 2008.

Quarterly revenue and operating results may fluctuate in future periods, and the Company may fail to meet investor expectations

        The Company's quarterly revenue and operating results have fluctuated significantly in the past, and are likely to continue to do so in the future due to a number of factors, many of which are not within the Company's control. If quarterly revenue or operating results fall below the expectations of

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investors, the price of the Company's common stock could decline significantly. Factors that might cause quarterly fluctuations in revenue and operating results include the following:

        The level of expenses incurred depends, in part, on the expectation for future revenue. In addition, since many expenses are fixed in the short term, the Company cannot significantly reduce expenses if there is a decline in revenue to avoid losses.

Stocks traded on the OTC Bulletin Board are subject to greater market risks than those of exchange-traded stocks since they are less liquid

        HemaCare's common stock was delisted from the Nasdaq Small Cap Market on October 29, 1998 because of the failure to maintain Nasdaq's requirement of a minimum bid price of $1.00. Since November 2, 1998, the common stock has traded on the OTC Bulletin Board, an electronic, screen-based trading system operated by the National Association of Securities Dealers, Inc. Securities traded on the OTC Bulletin Board are, for the most part, thinly traded and generally are not subject to the level of regulation imposed on securities listed or traded on the Nasdaq Stock Market or on another national securities exchange. As a result, an investor may find it difficult to dispose of the Company's common stock or to obtain accurate price quotations.

Stock price could be volatile

        The price of HemaCare's common stock has fluctuated in the past and may be more volatile in the future. Factors such as the announcements of government regulation, new products or services introduced by the Company or by the competition, healthcare legislation, trends in health insurance, litigation, fluctuations in operating results and market conditions for healthcare stocks in general could have a significant impact on the future price of HemaCare's common stock. In addition, the stock market has from time to time experienced extreme price and volume fluctuations that may be unrelated to the operating performance of particular companies. The generally low volume of trading in HemaCare's common stock makes it more vulnerable to rapid changes in price in response to market conditions.

Future sales of equity securities could dilute the Company's common stock

        The Company may seek new financing in the future through the sale of its securities. Future sales of common stock or securities convertible into common stock could result in dilution of the common stock currently outstanding. In addition, the perceived risk of dilution may cause some shareholders to sell their shares, which may further reduce the market price of the common stock.

Lack of dividend payments could impact the price of the Company's common stock

        The Company intends to retain any future earnings for use in its business, and therefore does not anticipate declaring or paying any cash dividends in the foreseeable future. The declaration and payment of any cash dividends in the future will depend on the Company's earnings, financial

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condition, capital needs and other factors deemed relevant by the Board of Directors. In addition, the Company's credit agreement prohibits the payment of dividends during the term of the agreement.

Evaluation of internal control and remediation of potential problems will be costly and time consuming and could expose weaknesses in financial reporting

        The regulations implementing Section 404 of the Sarbanes-Oxley Act of 2002 require management to perform an assessment of the effectiveness of the Company's internal control over financial reporting beginning with its Annual Report on Form 10-K for the fiscal year ending December 31, 2007. The Company's independent registered public accounting firm will be required to test and evaluate the design and effectiveness of such controls beginning with the Annual Report on Form 10-K for the fiscal year ending December 31, 2010.

        This process will be expensive and time consuming, and will require significant attention of management. This process has revealed material weaknesses in internal controls that will require remediation. See "Item 4T. Control and Procedures." The remediation process may also be expensive and time consuming, and management can give no assurance that the remediation effort will be completed on time or be effective. In addition, management can give no assurance that additional material weaknesses in internal controls will not be discovered. Management also can give no assurance that the process of evaluation and the auditor's attestation will be completed on time. The disclosure of a material weakness, even if quickly remedied, could reduce the market's confidence in the Company's financial statements and harm the Company's stock price, especially if a restatement of financial statements for past periods is required.

        If the Company is unable to adequately design its internal control systems, or prepare an "internal control report" to the satisfaction of the Company's auditors, the Company's auditors may issue a qualified opinion on the Company's financial statements.

Item 3.    Quantitative and Qualitative Disclosures About Market Risk

        As of September 30, 2009, the Company has $385,000 outstanding on the working capital line of credit with Wells Fargo and $78,000 outstanding on the capital expenditure line of credit both of which are based on a variable interest rate linked to the Wells Fargo prime interest rate. Accordingly, the Company's interest rate expense will fluctuate with changes in the Wells Fargo prime rate. If interest rates increase or decrease by 1% for the year, the Company's interest expense would increase or decrease by approximately $5,000 based on the Company's current indebtedness. The Wells Agreement, however, requires minimum monthly interest payments of $14,000, which means that the Company's interest expense will not begin to fluctuate with changes in the Wells Fargo prime rate until the amount of indebtedness borrowed under the Wells Agreement exceeds the amount wherein the calculated interest rate exceeds $14,000 per month. Therefore, the Company's risk to interest rate changes for the Wells Fargo credit line requires that the Company utilize a sufficient amount of the line to causes the calculated interest expense to exceed the minimum requirement.

Item 4T.    Controls and Procedures

        The Chief Executive Officer and the Chief Financial Officer of the Company, with the participation of the Company's management, carried out an evaluation of the effectiveness of the Company's disclosure controls and procedures pursuant to Exchange Act Rule 13a-15(b). At the conclusion of this evaluation, the Chief Executive Officer and the Chief Financial Officer concluded that, as of the end of the period covered by this report, the Company's disclosure controls and

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procedures are ineffective to provide reasonable assurance that information required to be disclosed in this report is:

        Management is not aware of any specific control weakness that resulted in a material misstatement in the Company's financial statements, and management does not believe any of its financial statements contain any material misstatements.

        Management is responsible for establishing and maintaining adequate internal control over financial reporting. Internal control over financial reporting is a process designed by, or under the supervision of, the Company's Chief Executive Officer and the Chief Financial Officer and implemented by the Company's Board of Directors, management and other personnel, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with GAAP.

        The Company's internal control over financial reporting includes those policies and procedures that: i) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the Company; ii) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with GAAP, and that receipts and expenditures of the Company are made only in accordance with authorizations of management and directors of the Company; and iii) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the Company's assets that could have a material impact on the financial statements.

        As discussed in the Company's Annual Report on Form 10-K for the year ended December 31, 2008, the Company's management, including the Chief Executive Officer, does not expect that the Company's disclosure controls and procedures, or the Company's internal controls over financial reporting, will necessarily prevent all fraud and material errors. An internal control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations on all internal control systems, the Company's internal control system can provide only reasonable assurance of achieving its objectives and no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within the Company have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the control. The design of any system of internal control is also based in part upon certain assumptions about the likelihood of future events, and can provide only reasonable, not absolute, assurance that any design will succeed in achieving its stated goals under all potential future conditions. Over time, controls may become inadequate because of changes in circumstances, or the degree of compliance with the policies and procedures may deteriorate.

        A significant deficiency is a control deficiency, or combination of control deficiencies, that adversely affects the Company's ability to initiate, authorize, record, process, or report external financial data reliably in accordance with GAAP such that there is more than a remote likelihood that a misstatement of the Company's annual or interim financial statements that is more than

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inconsequential will not be prevented or detected. An internal control material weakness is a significant deficiency, or combination of significant deficiencies, that results in more than a remote likelihood that a material misstatement of the annual or interim financial statements will not be prevented or detected.

        Management of the Company, including the Chief Executive Officer and Chief Financial Officer, conducted an evaluation of the effectiveness of the Company's internal control over financial reporting for 2008. In making this assessment, management used the criteria set forth in the Internal Control-Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission. The evaluation began with the identification and review of its company-level controls including the control environment, risk assessment process, monitoring results of operations and period-end financial reporting processes. Additionally, the evaluation included a complete risk assessment of all the Company's business processes and financial statement account categories based on the following weighted risk categories:

        Each financial statement account category was assigned a risk score of 1, 2 or 3, based on if an error might have no material impact on either the balance sheet or income statement, might have a material impact on either the balance sheet or income statement, or might have a material impact on both the balance sheet and income statement. A calculation was then performed for each financial statement account category to weight the score for each risk category. At the conclusion of this analysis, management identified those financial statement account categories that were perceived to be either high risk, medium risk or low risk for material error. Those categorized as high risk were selected for further evaluation of the related internal control structure.

        The Company's management, with the assistance of outside consultants, performed an evaluation of all of the internal controls related to the high and medium risk account categories including a review of the related business processes, review of related Company policies, interviews with key personnel and, where applicable, an assessment of related information technology controls. Management then designed and executed a testing plan to determine if any of these significant controls were effective or ineffective. In addition, management evaluated the Company's information technology general controls and automated application controls, including the design and execution of a testing plan to determine if these controls were effective.

        As a result of this evaluation, the Company identified the following material internal control weaknesses over financial reporting: (a) the Company failed to institute all elements of an effective program to help prevent and detect fraud by Company employees; (b) the Company did not maintain adequate segregation of duties for staff members responsible for recording revenue; (c) the Company failed to provide adequate controls over the use of spreadsheets used to record certain accounting entries and used to produce the Company's financial statements; and (d) the Company failed to provide adequate controls over the approvals of material journal entries.

        Therefore, the Chief Executive Officer and the Chief Financial Officer of the Company concluded that, as of the end of December 31, 2008, the Company's internal control over financial reporting was ineffective.

        Management does not believe any of its financial statements contain a material error as a result of any material weakness in internal controls.

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        Once management identified the specific internal controls that were deficient, management engaged in, and will continue to engage in, remediation efforts to address the material weakness in its internal control over financial reporting. Specific actions which have been or will be taken are outlined below:

        The Company has:

        The Company will assess the need to take additional actions including, but not limited, to the following:

        Other than the remedial actions discussed in the preceding section (c), there was no change in the Company's internal control over financial reporting known to the Chief Executive Officer or the Chief Financial Officer, that occurred during the Company's fiscal quarter ended September 30, 2009 that has materially impacted, or is reasonably likely to materially impact, the Company's internal control over financial reporting.

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PART II. OTHER INFORMATION

Item 1.    Legal Proceedings

        From time to time, the Company is involved in various routine legal proceedings incidental to the conduct of its business. Management does not believe that any of these legal proceedings will have a material adverse impact on the business, financial condition or results of operations of the Company, either due to the nature of the claims, or because management believes that such claims should not exceed the limits of the Company's insurance coverage.

Item 1A.    Risk Factors

        The risk factors disclosed in the "Risk Factors" section of the Company's Annual Report on Form 10-K for the year ended December 31, 2008 have not materially changed other than as set forth below:

Changes in demand for blood products could affect profitability

        The Company's operations are structured to produce particular blood products based on customers' existing demand, and perceived potential changes in demand, for these products. Sudden or unexpected changes in demand for these products could have an adverse impact on the Company's profitability. Increasing demand could harm relationships with customers if the Company is unable to alter production capacity, or purchase products from other suppliers, to fill orders adequately. This could result in a decrease in overall revenue and profits. Decreases in demand may require the Company to make sizeable investments to restructure operations away from declining products to the production of new products. Lack of access to sufficient capital, or lack of adequate time to properly respond to such a change in demand, could result in declining revenue and profits as customers transfer to other suppliers. Additionally, an increase in the supply of blood products in the marketplace could result in declining revenue and profits for the Company due to a market driven decrease in prices.

Discontinuation of the operations of the Company's Florida-based research subsidiary may hinder the Company's ability to generate profits

        The Company's Florida-based research subsidiary recorded a decrease in revenue and a related increase in operating losses throughout the first three quarters of 2007. On November 5, 2007, the Board of Directors of HemaBio closed this operation to avoid further losses. On December 4, 2007, HemaBio executed an Assignment for Benefit of Creditors, under Florida Statutes Section 727.101 et seq., assigning all of its assets to an assignee, who is responsible for taking possession of, protecting, preserving, and liquidating such assets and ultimately distributing the proceeds to creditors of HemaBio according to their priorities as established by Florida law. During 2008, the assignee successfully liquidated most of HemaBio's assets, including inventory, furniture and equipment. As of June 30, 2009, the assignee was still engaged to complete the liquidation and closure activities. These activities could temporarily increase costs, utilize scarce financial resources, distract management and have a material adverse impact on the Company and its results of operations. In addition, HemaBio creditors could attempt to pursue HemaCare for recovery of unpaid claims if they are not satisfied with the results of the Assignment for Benefit of Creditors process. If HemaBio's creditors are successful, HemaCare may not have sufficient liquidity to satisfy these obligations.

Federal legislative proposals relating to the provision of health care may have a material effect on the Company

        There are complex legislative proposals pending in the United States Congress relating to health care insurance coverage, cost containment and payments. It is not possible at this time to evaluate

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whether there will be a material impact on the Company's operations or profitability from any final legislative enactments in this area, nor from any regulatory actions pursuant to any such legislation.

Pandemic or epidemic outbreak of disease could significantly impact blood donations and have a material adverse impact on profitability

        If swine flu, avian flu, or other disease, were to develop into a worldwide pandemic, or epidemic in one or more of the regions in which the Company operates, the portion of the public that typically donates blood to the Company may be unable, or unwilling to donate, thereby significantly reducing the availability of blood that the Company relies upon to manufacture blood products. In addition, even if suspected diseases prove to be no more virulent than other more common disease, the heightened fear among the public resulting from widespread media coverage may result in dramatic decline in donations. Moreover, if a significant portion of the Company's workforce becomes ill, is required to stay home to care for ill family members, or is required to stay home in connection with social distancing programs intended to minimize disease transmission, the Company's operations could be significantly disrupted, which could have a material adverse impact on the Company's profitability.

Industry regulations and standards could increase operating costs or result in closure of operations

        The business of collecting, processing and distributing blood products is subject to extensive and complex regulation by the state and federal governments. The Company is required to obtain and maintain numerous licenses in different legal jurisdictions regarding the safety, purity and quality of products, condition of facilities and that appropriate procedures are utilized. Periodically the FDA conducts inspections of HemaCare's facilities and operations. At the conclusion of each inspection, the FDA provides the Company with a list, if any, of observations of regulatory issues discovered during the inspection. On May 5, 2006, the Company received a warning letter from the FDA pertaining to specific observations from an inspection of the Company's California operations earlier that year. In August of 2007, the FDA performed another inspection of the Company's California operations. As a result of this inspection, the FDA provided the Company with a list of observations of regulatory issues, but took no further regulatory action. In July of 2009, the FDA performed another inspection of the Company's California operations. As a result of this inspection, the FDA provided the Company with a list of observations of regulatory issues, but none of the observations were repeat observations from previous inspections.

        The Company believes it has either adequately addressed the issues raised by the FDA, or is in the process of addressing these issues. The Company believes that its response and actions taken to address the FDA observations are sufficient that it is in compliance with current FDA regulations; however, the Company cannot insure against future FDA actions, including possible sanctions or closure of selected Company operations.

        On October 12, 2006, the AABB issued a timeline for gradual implementation of the United States Industry Consensus Standards for the Uniform Labeling of Blood and Blood Components using ISBT 128. To maintain accreditation, blood facilities would need to develop a written implementation plan by November 1, 2006 and complete full implementation by May 2008. The Company requested and received a variance from the AABB to delay the deadline for full implementation until December 31, 2008. In July 2009, the AABB announced that member organizations who fail to convert to ISBT 128 by November 1, 2009 will be subject to a change in their accreditation status to "conditional". The Company is in the process to convert to ISBT 128, but may not complete the conversion by the November 1, 2009 deadline. If so, the change in the Company's AABB accreditation status could impact the Company's relationship with selected customers who require blood suppliers to be AABB accredited.

        State and federal laws include anti-kickback and self-referral prohibitions and other regulations that affect the shipment of blood products and the relationships between blood banks, hospitals,

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physicians and other persons who refer business to each other. Health insurers and government payers, such as Medicare and Medicaid, also limit reimbursement for products and services, and require compliance with certain regulations before reimbursement will be made.

        The Company devotes substantial resources to complying with laws and regulations; however, the possibility cannot be eliminated that interpretations of existing laws and regulations will result in findings that the Company has not complied with existing regulations. Such a finding could materially harm the Company's business. Moreover, healthcare reform is continually under consideration by regulators, and the Company does not know how laws and regulations will change in the future.

Item 2.    Unregistered Sales of Equity Securities and Use of Proceeds

        The Wells Agreement requires the maintenance of certain covenants that, among other things, require minimum levels of profitability and prohibit the payment of dividends.

Item 3.    Defaults Upon Senior Securities

        None.

Item 4.    Submission of Matters to a Vote of Security Holders

        None.

Item 5.    Other Information

        None.

Item 6.    Exhibits

3.1   Restated Articles of Incorporation of the Registrant incorporated by reference to Exhibit 3.1 to Form 10-K of the Registrant for the year ended December 31, 2002.

3.2

 

Amended and Restated Bylaws of the Registrant, as amended, incorporated by reference to Exhibit 3.1 to Form 8-K of the Registrant filed on March 28, 2007.

4.1

 

Rights Agreement between the Registrant and U.S. Stock Transfer Corporation dated March 3, 1998, incorporated by reference to Exhibit 4 to Form 8-K of the Registrant dated March 5, 1998.

4.1.1

 

Amendment and Extension of Rights Agreement dated as of March 3, 1998, between HemaCare Corporation and Computershare Trust Company, N.A., incorporated by reference to Exhibit 99.1 to Registrant's Current Report on Form 8-K filed on March 24. 2008.

4.2

 

Form of Common Stock Certificate, incorporated by reference to Exhibit 4.4 to Form S-8 of the Registrant dated July 10, 2006.

11

 

Net Income per Common and Common Equivalent Share

31.1

 

Certification Pursuant to Rule 13a-14(a) Under the Securities Exchange Act

31.2

 

Certification Pursuant to Rule 13a-14(a) Under the Securities Exchange Act

32.1

 

Certification Pursuant to 18 U.S.C. 1350 and Rule 13a-14(b) Under the Securities Exchange Act of 1934

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Table of Contents


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, thereunto duly authorized.

Date   November 12, 2009

  HEMACARE CORPORATION
(Registrant)

 

 

 

 

By:

 

/s/ JOHN DOUMITT

John Doumitt, Chief Executive Officer

 

 

 

 

By:

 

/s/ ROBERT S. CHILTON

Robert S. Chilton, Chief Financial Officer

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Table of Contents


EXHIBIT INDEX

  3.1   Restated Articles of Incorporation of the Registrant incorporated by reference to Exhibit 3.1 to Form 10-K of the Registrant for the year ended December 31, 2002.

 

3.2

 

Amended and Restated Bylaws of the Registrant, as amended, incorporated by reference to Exhibit 3.1 to Form 8-K of the Registrant filed on March 28, 2007.

 

4.1

 

Rights Agreement between the Registrant and U.S. Stock Transfer Corporation dated March 3, 1998, incorporated by reference to Exhibit 4 to Form 8-K of the Registrant dated March 5, 1998.

 

4.1.1

 

Amendment and Extension of Rights Agreement dated as of March 3, 1998, between HemaCare Corporation and Computershare Trust Company, N.A., incorporated by reference to Exhibit 99.1 to Registrant's Current Report on Form 8-K filed on March 24. 2008.

 

4.2

 

Form of Common Stock Certificate, incorporated by reference to Exhibit 4.4 to Form S-8 of the Registrant dated July 10, 2006.

 

11

 

Net Income per Common and Common Equivalent Share

 

31.1

 

Certification Pursuant to Rule 13a-14(a) Under the Securities Exchange Act

 

31.2

 

Certification Pursuant to Rule 13a-14(a) Under the Securities Exchange Act

 

32.1

 

Certification Pursuant to 18 U.S.C. 1350 and Rule 13a-14(b) Under the Securities Exchange Act of 1934

44