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SEC Company Response from QUESTCOR PHARMACEUTICALS INC (CIK 0000891288) — Jun 15, 2005

QUESTCOR PHARMACEUTICALS INC (CIK 0000891288)
Date: June 15, 2005 · CIK: 0000891288 · Accession: 0000950134-05-012032

AI Filing Summary & Sentiment

Referenced dates: May 3, 2005

Date
June 15, 2005
Author
Not clearly detected
Form
CORRESP
Company
QUESTCOR PHARMACEUTICALS INC (CIK 0000891288)

Letter

Attention: RE: Questcor Pharmaceuticals, Inc. Form 10-K for the fiscal year ended December 31, 2004 File No. 1-14758

Dear Mr. Rosenberg:

Questcor Pharmaceuticals, Inc. (the “Company”) is in receipt of your letter dated May 3, 2005 with respect to the Company’s Form 10-K for the fiscal year ended December 31, 2004 (“Form 10-K”). We have responded to your comments as set forth below. For ease of reference, we have set forth the Staff’s comments and the Company’s response for each item below. Capitalized terms used but not otherwise defined herein have the meanings assigned to such terms in Form 10-K.

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

Critical Accounting Policies

Sales Reserves, Product Returns, and Rebates, pages 28-30

1.

Staff Comment No. 1: We believe your disclosure related to estimates of items that reduce gross revenue such as product returns and rebates could be improved as follows:

a.

Staff Comment No. 1a: Disclose the nature and amount of each accrual at the balance sheet date and the effect that could result from using other reasonably likely assumptions than what you used to arrive at each accrual such as a range of reasonably likely amounts or other type of sensitivity analysis.

Company Response: The Company describes and discloses in Item 7, Management’s Discussion and Analysis, Critical Accounting Policies, on page 28 of Form 10-K, the nature of the accruals for which the related expenses reduce gross revenue, namely expenses resulting from reserves for product returns, government chargebacks, Medicaid rebates, and cash discounts. In the Company’s opinion, no other accruals are or should be recorded the expense related to which would reduce gross revenue under generally accepted accounting principles.

With the exception of the reserve for product returns under the credit memoranda policy, the amounts of the sales accruals or reserves are not individually material in relation to total current liabilities or total liabilities and shareholders’ equity as of December 31, 2004. The sum of the reserves for government chargebacks, Medicaid rebates, and replacements under the product exchange policy constitutes less than 8% of total current liabilities and less than 3% of total liabilities and shareholders’ equity. The allowance for cash discounts constitutes less than 2% of accounts receivable before allowances for doubtful accounts and cash discounts. The reserve for product returns under the credit memoranda policy, which is material and is disclosed separately, constitutes approximately 12% and approximately 4% of total current liabilities and total liabilities and shareholders’ equity, respectively. The amount of the reserve for product returns under the credit memoranda policy is disclosed individually in Management’s Discussion and Analysis, Critical Accounting Policies, on page 29 of Form 10-K, and in Note 1 to the Consolidated Financial Statements, on page 64 of Form 10-K.

The expenses related to the sales reserves are not individually material in relation to gross sales for either 2003 or 2004. For 2003, none of the expenses related to the sales reserves individually constituted more than 4% of product sales before deduction of such expenses, and in total were less than 9% of product sales before deduction of such expenses. For 2004, none of the expenses related to the sales reserves, other than the reserve for product returns under the credit memoranda policy, individually constituted more than 4% of product sales before deduction of such expenses, and in total were less than 8% of product sales before deduction of such expenses. The 2004 expense related to the reserve for product returns under the credit memoranda policy is individually disclosed in Form 10-K, as described in the preceding paragraph.

The Company believes that the assumptions used to estimate the sales reserves are the most reasonably likely assumptions and that the range of other substantially less likely assumptions would not produce results materially different from those which were recorded.

b.

Staff Comment No. 1b: Disclose the factors that you consider in estimating each accrual such as historical return of products, levels of inventory in the distribution channel, estimated remaining shelf life, price changes from competitors and introductions of generics and/or new products.

The Company has disclosed all factors considered in estimating each sales reserve accrual in Item 7, Management’s Discussion and Analysis, Critical Accounting Policies, and in Note 1 to the Financial Statements of Form 10-K.

The Company considers the following factors in estimating product returns from wholesalers, hospitals and pharmacies: i) historical returns and sales patterns; ii) current inventory on hand at wholesalers and the remaining shelf life of that inventory; iii) changes in demand measured by prescriptions or other data as provided by an independent third party source and the Company’s internal estimates; iv) analysis of return merchandise authorizations; and v) returns received. These factors are disclosed in Item 7, Management’s Discussion and Analysis, Critical Accounting Policies, on page 29 of Form 10-K, and in Note 1 to the Consolidated Financial Statements on page 63 of Form 10-K.

The Company considers the following factors in estimating government chargebacks for goods purchased by certain Federal government organizations including the Veterans Administration: i) actual chargeback amounts by product; and ii) sales to which chargebacks apply. These factors are disclosed in Item 7, Management’s Discussion and Analysis, Critical Accounting Policies, on page 30 of Form 10-K.

The Company considers the following factors in estimating Medicaid rebates: i) historical percentage of actual rebates to quantity of product sold by pharmacies; ii) sales to which rebates apply; and iii) Medicaid allowable prices. These factors are disclosed in Item 7, Management’s Discussion and Analysis, Critical Accounting Policies, on page 30 of Form 10-K.

c.

Staff Comment No. 1c: To the extent that information you consider in b) is quantifiable, disclose both quantitative and qualitative information and discuss to what extent information is from external sources, such as end-customer prescription demand, third-party market research data comparing wholesaler inventory levels to end-customer demand. For example, in discussing your estimate of product that may be returned, consider disclosing and discussing, preferably by product and in tabular format, the total amount of product in sales dollars that could be potentially be returned as of the balance sheet date and disaggregated by expiration period.

Company Response: The Company discloses which factors used in estimating sales reserves are based on external information sources and which are based on internally-generated data in its descriptions of the factors which it uses. As described in the Company’s response to Staff Comment 1b, the following are factors based on external information sources: i) current inventory on hand at wholesalers; ii) changes in demand measured by prescriptions or other data as provided by an independent third party source; iii) quantity of product sold by pharmacies; and v) Medicaid allowable prices.

The factors which the Company considers in estimating each sales reserve accrual are not individually quantitatively significant to the estimation. The Company uses a combination of individual factors in estimating each sales reserve accrual, as described in the Company’s response to Staff Comment 1b, so that disclosure of each individual factor would not provide information meaningful to an evaluation of the Company’s financial position or results of operations.

The Company discloses the total amount of product in sales dollars that could potentially be returned under the Company’s credit memoranda policy as of the balance sheet date in Item 7, Management’s Discussion and Analysis, Critical Accounting Policies, on page 29 of Form 10-K in the statement, “A reserve for the sales value of estimated returns on shipments of Acthar and Nascobal product lots released and shipped after May 31, 2004 has been recorded as a liability in the amount of $1,054,000 as of December 31, 2004.” The Company proposes to provide additional disclosure regarding the gross sales value of product which customers have requested to be replaced, which has not yet been replaced as of December 31, 2004. Exhibit A attached herewith presents the Company’s proposed revision to Form 10-K, Item 7, Management’s Discussion and Analysis, Results of Operations, for the fiscal year ended December 31, 2004. The Company does not accept product returns for Glofil and VSL#3.

As product returns are accepted for a six-month period after expiration of the product lot, and the Company is unable to predict with certainty when within that six-month period the product returns may occur, the Company believes that presentation of potential product returns in sales dollars disaggregated by expiration period would not provide information meaningful to an evaluation of the Company’s financial position or results of operations.

d.

Staff Comment No. 1d: If applicable, discuss any shipments made as a result of incentives and/or in excess of your customer’s ordinary course of business inventory level. Discuss your revenue recognition policy for such shipments.

Company Response: The Company does not give any incentives to its customers to encourage product sales, and therefore discussion of a revenue recognition policy relating to such incentives is not applicable. Volume discounts were given for purchases of VSL#3, but such discounts were offered in the normal course of business to all customers throughout the year, were not restricted as to customer or time period, and are reflected in net product sales. Net product sales for VSL#3 in fiscal year 2004 represented approximately 8% of total net product sales. Volume discounts for VSL#3 represented approximately 12% of VSL#3 gross product sales, and less than 1% of total gross product sales. Therefore, the Company believes that disclosure of volume discounts given for purchases of VSL#3 is not meaningful nor is it material to the financial results. In January 2005, the VSL#3 promotion agreement expired in accordance with its terms, and the product will be sold in the future by Sigma-Tau Pharmaceuticals.

The business inventory levels of the Company’s wholesaler customers vary continuously based upon prescription demand and its customers’ individual and unique internal business operating policies and requirements. The Company is not privy to its customers’ business operating policies and requirements regarding inventory levels, and therefore has no knowledge as to what its customers’ “ordinary course of business inventory level” is. Therefore, the Company believes that a discussion of a revenue recognition policy relating to such shipments, if any, is not applicable.

e.

Staff Comment No. 1e: You should consider disclosing a roll forward of the accrual for each estimate for each period presented showing the following:

•

Beginning balance,

•

Current provision related to sales made in current period,

•

Current provision related to sales made in prior periods

•

Actual returns or credits in current period related to sales made in current period,

•

Actual returns or credits in current period related to sales made in prior periods, and

•

Ending balance.

Company Response: The Company believes the roll forward disclosure contained in Schedule II Valuation and Qualifying Accounts in Form 10-K provides adequate disclosure of transactions relating to sales reserves, considering the relative dollar amount of the liabilities recorded and the nature of the Company’s business operations. In addition, it is not practical or possible for the Company to provide information on actual returns or credits by period in which related sales were made.

With the exception of the reserve for product returns under the credit memoranda policy, the amounts of the sales accruals or reserves are not individually material in relation to total current liabilities or total liabilities and shareholders’ equity as of December 31, 2004. The sum of the reserves for government chargebacks, Medicaid rebates, and replacements under the product exchange policy constitutes less than 8% of total current liabilities and less than 3% of total liabilities and shareholders’ equity. The allowance for cash discounts constitutes less than 2% of accounts receivable before allowances for doubtful accounts and cash discounts. The reserve for product returns under the credit memoranda policy, which is material and is disclosed separately, constitutes approximately 12% and approximately 4% of total current liabilities and total liabilities and shareholders’ equity, respectively. The amount of the reserve for product returns under the credit memoranda policy is disclosed individually in Management’s Discussion and Analysis, Critical Accounting Policies, on page 29 of Form 10-K, and in Note 1 to the Consolidated Financial Statements, on page 64 of Form 10-K.

The expenses related to the sales reserves are not individually material in relation to gross sales for either 2003 or 2004. For 2003, none of the expenses related to the sales reserves individually constituted more than 4% of product sales before deduction of such expenses, and in total were less than 9% of product sales before deduction of such expenses. For 2004, none of the expenses related to the sales reserves, other than the reserve for product returns under the credit memoranda policy, individually constituted more than 4% of product sales before deduction of such expenses, and in total were less than 8% of product sales before deduction of such expenses. The 2004 expense related to the reserve for product returns under the credit memoranda policy is individually disclosed in Form 10-K, as described in the preceding paragraph.

The current period expense recorded for each sales reserve relates primarily to sales made in the current period. The Company believes any portion of the current period expense which might relate to prior period sales would be the result of adjustments to factors used in estimating the provision. The Company believes such adjustments are not material in relation to the current period expense.

The Company sells products to wholesalers, who in turn sell these products to pharmacies and hospitals. The hospitals or state Medicaid agencies are the entities which submit requests for VA chargebacks or Medicaid rebates to the Company. The Company believes it is not practical and may not even be possible to determine when the hospital or state Medicaid agency purchased product from the wholesaler, and correspondingly when that wholesaler purchased that product from the Company. Therefore, it is not possible for the Company to match VA chargebacks or Medicaid rebates with sales made during a particular fiscal year.

Product returns can be identified with a particular product lot, however, such lots are not sold within discrete fiscal years. Therefore, it is not possible for the Company to match returns with sales made during a particular fiscal year.

f.

Staff Comment No. 1f: In your discussion of results of operations for the period to period revenue comparisons, discuss the amount of and reason for fluctuations for each type of reduction of gross revenue, i.e. product returns, customer rebates

Show Raw Text
CORRESP
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corresp

[QUESTCOR LETTERHEAD]

June 15, 2005

VIA FACSIMILE AND EDGAR

U.S. Securities and Exchange Commission

450 Fifth Street, N.W.

Washington, D.C. 20549

    Attention:

    Jim B. Rosenberg, Senior Assistant Chief Accountant

    RE:

    Questcor Pharmaceuticals, Inc.

    Form 10-K for the fiscal year ended December 31, 2004

    File No. 1-14758

Dear Mr. Rosenberg:

     Questcor Pharmaceuticals, Inc. (the “Company”) is in receipt of your letter dated May 3, 2005
with respect to the Company’s Form 10-K for the fiscal year ended December 31, 2004 (“Form 10-K”).
We have responded to your comments as set forth below. For ease of reference, we have set forth
the Staff’s comments and the Company’s response for each item below. Capitalized terms used but
not otherwise defined herein have the meanings assigned to such terms in Form 10-K.

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

Critical Accounting Policies

Sales Reserves, Product Returns, and Rebates, pages 28-30

    1.

    Staff Comment No. 1: We believe your disclosure related to estimates of items that reduce
gross revenue such as product returns and rebates could be improved as follows:

    a.

    Staff Comment No. 1a: Disclose the nature and amount of each accrual at the balance sheet
date and the effect that could result from using other reasonably likely assumptions than what
you used to arrive at each accrual such as a range of reasonably likely amounts or other type
of sensitivity analysis.

Company Response: The Company describes and discloses in Item 7, Management’s Discussion
and Analysis, Critical Accounting Policies, on page 28 of Form 10-K, the nature of the
accruals for which the related expenses reduce gross revenue, namely expenses resulting
from reserves for product returns, government chargebacks, Medicaid rebates, and cash
discounts. In the Company’s opinion, no other accruals are or should be recorded the
expense related to which would reduce gross revenue under generally accepted accounting
principles.

With the exception of the reserve for product returns under the credit memoranda policy,
the amounts of the sales accruals or reserves are not individually material in relation to
total current liabilities or total liabilities and shareholders’ equity as of December 31,
2004. The sum of the reserves for government chargebacks, Medicaid rebates, and
replacements under the product exchange policy constitutes less than 8% of total current
liabilities and less than 3% of total liabilities and shareholders’ equity. The allowance
for cash discounts constitutes less than 2% of accounts receivable before allowances for
doubtful accounts and cash discounts. The reserve for product returns under the credit
memoranda policy, which is material and is disclosed separately, constitutes approximately
12% and approximately 4% of total current liabilities and total liabilities and
shareholders’ equity, respectively. The amount of the reserve for product returns under the
credit memoranda policy is disclosed individually in Management’s Discussion and Analysis,
Critical Accounting Policies, on page 29 of Form 10-K, and in Note 1 to the Consolidated
Financial Statements, on page 64 of Form 10-K.

The expenses related to the sales reserves are not individually material in relation to
gross sales for either 2003 or 2004. For 2003, none of the expenses related to the sales
reserves individually constituted more than 4% of product sales before deduction of such
expenses, and in total were less than 9% of product sales before deduction of such
expenses. For 2004, none of the expenses related to the sales reserves, other than the
reserve for product returns under the credit memoranda policy, individually constituted
more than 4% of product sales before deduction of such expenses, and in total were less
than 8% of product sales before deduction of such expenses. The 2004 expense related to
the reserve for product returns under the credit memoranda policy is individually disclosed
in Form 10-K, as described in the preceding paragraph.

The Company believes that the assumptions used to estimate the sales reserves are the most
reasonably likely assumptions and that the range of other substantially less likely
assumptions would not produce results materially different from those which were recorded.

    b.

    Staff Comment No. 1b: Disclose the factors that you consider in estimating each accrual such
as historical return of products, levels of inventory in the distribution channel, estimated
remaining shelf life, price changes from competitors and introductions of generics and/or new
products.

The Company has disclosed all factors considered in estimating each sales reserve accrual
in Item 7, Management’s Discussion and Analysis, Critical Accounting Policies, and in Note
1 to the Financial Statements of Form 10-K.

The Company considers the following factors in estimating product returns from wholesalers,
hospitals and pharmacies: i) historical returns and sales patterns; ii) current inventory
on hand at wholesalers and the remaining shelf life of that inventory; iii) changes in
demand measured by prescriptions or other data as provided by an independent third party
source and the Company’s internal estimates; iv) analysis of return merchandise
authorizations; and v) returns received. These factors are disclosed in Item 7,
Management’s Discussion and Analysis, Critical Accounting Policies, on page 29 of Form
10-K, and in Note 1 to the Consolidated Financial Statements on page 63 of Form 10-K.

The Company considers the following factors in estimating government chargebacks for goods
purchased by certain Federal government organizations including the Veterans
Administration: i) actual chargeback amounts by product; and ii) sales to which chargebacks
apply. These factors are disclosed in Item 7, Management’s Discussion and Analysis,
Critical Accounting Policies, on page 30 of Form 10-K.

The Company considers the following factors in estimating Medicaid rebates: i) historical
percentage of actual rebates to quantity of product sold by pharmacies; ii) sales to which
rebates apply; and iii) Medicaid allowable prices. These factors are disclosed in Item 7,
Management’s Discussion and Analysis, Critical Accounting Policies, on page 30 of Form
10-K.

    c.

    Staff Comment No. 1c: To the extent that information you consider in b) is quantifiable,
disclose both quantitative and qualitative information and discuss to what extent information
is from external sources, such as end-customer prescription demand, third-party market
research data comparing wholesaler inventory levels to end-customer demand. For example, in
discussing your estimate of product that may be returned, consider disclosing and discussing,
preferably by product and in tabular format, the total amount of product in sales dollars that
could be potentially be returned as of the balance sheet date and disaggregated by expiration
period.

Company Response: The Company discloses which factors used in estimating sales reserves
are based on external information sources and which are based on internally-generated data
in its descriptions of the factors which it uses. As described in the Company’s response
to Staff Comment 1b, the following are factors based on external information sources: i)
current inventory on hand at wholesalers; ii) changes in demand measured by prescriptions
or other data as provided by an independent third party source; iii) quantity of product
sold by pharmacies; and v) Medicaid allowable prices.

The factors which the Company considers in estimating each sales reserve accrual are not
individually quantitatively significant to the estimation. The Company uses a combination
of individual factors in estimating each sales reserve accrual, as described in the
Company’s response to Staff Comment 1b, so that disclosure of each individual factor would
not provide information meaningful to an evaluation of the Company’s financial position or
results of operations.

The Company discloses the total amount of product in sales dollars that could potentially
be returned under the Company’s credit memoranda policy as of the balance sheet date in
Item 7, Management’s Discussion and Analysis, Critical Accounting Policies, on page 29 of
Form 10-K in the statement, “A reserve for the sales value of estimated returns on
shipments of Acthar and Nascobal product lots released and shipped after May 31, 2004 has
been recorded as a liability in the amount of $1,054,000 as of December 31, 2004.” The
Company proposes to provide additional disclosure regarding the gross sales value of
product which customers have requested to be replaced, which has not yet been replaced as
of December 31, 2004. Exhibit A attached herewith presents the Company’s proposed revision
to Form 10-K, Item 7, Management’s Discussion and Analysis, Results of Operations, for the
fiscal year ended December 31, 2004. The Company does not accept product returns for
Glofil and VSL#3.

As product returns are accepted for a six-month period after expiration of the product lot,
and the Company is unable to predict with certainty when within that six-month period the
product returns may occur, the Company believes that presentation of potential product
returns in sales dollars disaggregated by expiration period would not provide information
meaningful to an evaluation of the Company’s financial position or results of operations.

    d.

    Staff Comment No. 1d: If applicable, discuss any shipments made as a result of incentives
and/or in excess of your customer’s ordinary course of business inventory level. Discuss your
revenue recognition policy for such shipments.

Company Response: The Company does not give any incentives to its customers to encourage
product sales, and therefore discussion of a revenue recognition policy relating to such
incentives is not applicable. Volume discounts were given for purchases of VSL#3, but such
discounts were offered in the normal course of business to all customers throughout the
year, were not restricted as to customer or time period, and are reflected in net product
sales. Net product sales for VSL#3 in fiscal year 2004 represented approximately 8% of
total net product sales. Volume discounts for VSL#3 represented approximately 12% of VSL#3
gross product sales, and less than 1% of total gross product sales. Therefore, the Company
believes that disclosure of volume discounts given for purchases of VSL#3 is not meaningful
nor is it material to the financial results. In January 2005, the VSL#3 promotion
agreement expired in accordance with its terms, and the product will be sold in the future
by Sigma-Tau Pharmaceuticals.

The business inventory levels of the Company’s wholesaler customers vary continuously based
upon prescription demand and its customers’ individual and unique internal business
operating policies and requirements. The Company is not privy to its customers’ business
operating policies and requirements regarding inventory levels, and therefore has no
knowledge as to what its customers’ “ordinary course of business inventory level” is.
Therefore, the Company believes that a discussion of a revenue recognition policy relating
to such shipments, if any, is not applicable.

    e.

    Staff Comment No. 1e: You should consider disclosing a roll forward of the accrual for each
estimate for each period presented showing the following:

    •

    Beginning balance,

    •

    Current provision related to sales made in current period,

    •

    Current provision related to sales made in prior periods

    •

    Actual returns or credits in current period related to sales made in current
period,

    •

    Actual returns or credits in current period related to sales made in prior periods,
and

    •

    Ending balance.

Company Response: The Company believes the roll forward disclosure contained in Schedule II
Valuation and Qualifying Accounts in Form 10-K provides adequate disclosure of transactions
relating to sales reserves, considering the relative dollar amount of the liabilities
recorded and the nature of the Company’s business operations. In addition, it is not
practical or possible for the Company to provide information on actual returns or credits
by period in which related sales were made.

With the exception of the reserve for product returns under the credit memoranda policy,
the amounts of the sales accruals or reserves are not individually material in relation to
total current liabilities or total liabilities and shareholders’ equity as of December 31,
2004. The sum of the reserves for government chargebacks, Medicaid rebates, and
replacements under the product exchange policy constitutes less than 8% of total current
liabilities and less than 3% of total liabilities and shareholders’ equity. The allowance
for cash discounts constitutes less than 2% of accounts receivable before allowances for
doubtful accounts and cash discounts. The reserve for product returns under the credit
memoranda policy, which is material and is disclosed separately, constitutes approximately
12% and approximately 4% of total current liabilities and total liabilities and
shareholders’ equity, respectively. The amount of the reserve for product returns under the credit
memoranda policy is disclosed individually in Management’s Discussion and Analysis,
Critical Accounting Policies, on page 29 of Form 10-K, and in Note 1 to the Consolidated
Financial Statements, on page 64 of Form 10-K.

The expenses related to the sales reserves are not individually material in relation to
gross sales for either 2003 or 2004. For 2003, none of the expenses related to the sales
reserves individually constituted more than 4% of product sales before deduction of such
expenses, and in total were less than 9% of product sales before deduction of such
expenses. For 2004, none of the expenses related to the sales reserves, other than the
reserve for product returns under the credit memoranda policy, individually constituted
more than 4% of product sales before deduction of such expenses, and in total were less
than 8% of product sales before deduction of such expenses. The 2004 expense related to
the reserve for product returns under the credit memoranda policy is individually disclosed
in Form 10-K, as described in the preceding paragraph.

The current period expense recorded for each sales reserve relates primarily to sales made
in the current period. The Company believes any portion of the current period expense which might
relate to prior period sales would be the result of adjustments to factors used in
estimating the provision. The Company believes such adjustments are not material in
relation to the current period expense.

The Company sells products to wholesalers, who in turn sell these products to pharmacies
and hospitals. The hospitals or state Medicaid agencies are the entities which submit
requests for VA chargebacks or Medicaid rebates to the Company. The Company believes it is
not practical and may not even be possible to determine when the hospital or state Medicaid
agency purchased product from the wholesaler, and correspondingly when that wholesaler
purchased that product from the Company. Therefore, it is not possible for the Company to
match VA chargebacks or Medicaid rebates with sales made during a particular fiscal year.

Product returns can be identified with a particular product lot, however, such lots are not
sold within discrete fiscal years. Therefore, it is not possible for the Company to match
returns with sales made during a particular fiscal year.

    f.

    Staff Comment No. 1f: In your discussion of results of operations for the period to period
revenue comparisons, discuss the amount of and reason for fluctuations for each type of
reduction of gross revenue, i.e. product returns, customer rebates