February 1, 2005
BY EDGAR
U.S. Securities and Exchange Commission
450 Fifth Street, N.W.
Washington, D.C. 20549-0303
Attention: Jim B. Rosenberg, Senior Assistant Chief Accountant
Re: Barr Pharmaceuticals, Inc.
Form 10-K for the fiscal year ended June 30, 2004
File No. 001-09860
Dear Mr. Rosenberg:
We are in receipt of your letter to Barr Pharmaceuticals, Inc. (the
"Company") of January 7, 2005 (the "Commission Letter"). The Company's responses
to the Commission Letter are set forth below. For ease of reference, the
numbered paragraphs below correspond to the numbered comments in the Commission
Letter.
ITEM 1. BUSINESS, PAGE 3
COMMENT 1. PLEASE PROVIDE A BRIEF DESCRIPTION OF THE OVERALL FDA APPROVAL
PROCESS. THE DESCRIPTION SHOULD MEANINGFULLY RELATE TO THE REGISTRANT'S
ACCOUNTING POLICY FOR PRE-LAUNCH INVENTORY.
RESPONSE: We have noted the Staff's comments and will expand our discussion in
the Business section of our future filings beginning with the Form 10-K for the
year ending June 30, 2005, which we anticipate to be the Company's next filing
that will contain a Business section.
MANAGEMENT DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
COMPARISON OF THE FISCAL YEARS ENDED JUNE 30, 2004 AND JUNE 30, 2003, PAGE 32
COMMENT 2. WHEN MORE THAN ONE REASON IS RESPONSIBLE FOR A FLUCTUATION, YOU
SHOULD QUANTIFY EACH OF THE FACTORS CAUSING THE CHANGE. IN THIS REGARD, YOU NOTE
SEVERAL REASONS FOR YOUR INCREASE IN SELLING, GENERAL AND ADMINISTRATIVE
EXPENSES FROM 2003 TO 2004, SUCH AS INCREASES IN MARKETING COSTS FOR SEASONALE,
HIGHER COSTS ASSOCIATED WITH INCREASING WOMEN'S HEALTHCARE SALES FORCE, HIGHER
LEGAL COSTS, AND INCREASED INFORMATION TECHNOLOGY COSTS. IN FUTURE FILINGS,
PLEASE QUANTIFY THE EFFECTS OF EACH FACTOR ON THE INCREASES AND DECREASES IN A
LINE ITEM BEING DISCUSSED.
RESPONSE: We have noted the Staff's comments and will, in future filings,
beginning with the Form 10-Q for the quarter ended December 31, 2004 (which we
will file no later than
Mr. Jim B. Rosenberg
U.S. Securities and Exchange Commission
February 1, 2005
Page 2
February 9th), where practical, quantify the effects of each factor causing a
significant increase or decrease in the line item being discussed.
CRITICAL ACCOUNTING POLICIES
REVENUE RECOGNITION AND SALES RESERVES AND ALLOWANCES, PAGE 45
COMMENT 3. WE ACKNOWLEDGE YOUR REVENUE RECOGNITION POLICY WITHIN YOUR SUMMARY OF
SIGNIFICANT ACCOUNTING POLICIES WITHIN YOUR NOTES TO THE CONSOLIDATED FINANCIAL
STATEMENTS. WE BELIEVE THAT YOUR DISCLOSURE RELATED TO ESTIMATES OF ITEMS THAT
REDUCE GROSS REVENUE SUCH AS PRODUCT RETURNS, CHARGEBACKS, CUSTOMER REBATES,
SHELF STOCK ADJUSTMENTS AND OTHER DISCOUNTS AND ALLOWANCES COULD BE IMPROVED AS
FOLLOWS:
A) 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.
RESPONSE: Commencing with the filing of our Form 10-Q for the quarter ended
December 31, 2004, we will include a table detailing the amount of each of our
significant accruals -- for example, returns & allowances, chargebacks and
rebates --, for each balance sheet presented and provide expanded disclosure
discussing the nature of each accrual. In addition, we will expand our Critical
Accounting Policies disclosure in MD&A about the estimates and factors used in
developing our accruals, and will describe, when applicable, when changes in our
methodology or assumptions used in developing our estimates have a material
impact on our operating results.
We have considered your request for disclosing the "effect that could
result from using other reasonably likely assumptions than what you used to
arrive at each accrual" and respectfully submit that the objectives of such
disclosure could be better served by expanding the discussion regarding the
estimates and factors used in developing our accruals, as noted above. For
example, our accrual for cash discounts accounts for the prompt payment discount
offered to our customers. It is calculated based on a percentage of the invoice
price and our estimate as to the percentage of aggregate sales for which
customers will take advantage of the discount (with such estimate based on the
historical payment practices of our customers). Providing disclosure about the
impact of using a slightly higher or lower estimate of sales for which customers
will take advantage of the prompt payment discount would not provide investors
with very useful information. In addition, our accruals for returns & allowances
and chargebacks are based on multiple factors and, in turn, each factor is based
on multiple assumptions and estimates. Using other assumptions for these
individual factors can have competing effects on the accrual balance in any
given quarter. As a result, attempting to provide disclosure about the impact of
using other assumptions requires multiple variables to be increased or decreased
and would result in a level of disclosure and a range of potential outcomes that
would de-emphasize material information.
Mr. Jim B. Rosenberg
U.S. Securities and Exchange Commission
February 1, 2005
Page 3
B) 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.
RESPONSE: We direct the Staff to pages 45-46 in our Form 10-K for the year ended
June 30, 2004 where we disclosed the significant factors used in determining our
key accruals noted in 3 a. above. We will review our current disclosure of the
factors we use in establishing our accruals and, commencing with our Form 10-Q
for the quarter ended December 31, 2004, will provide expanded disclosure in our
Critical Accounting Policies in MD&A.
C) TO THE EXTENT THAT THE 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.
RESPONSE: We will expand our Critical Accounting Policies disclosure in MD&A,
beginning with our Form 10-Q for the quarter ended December 31, 2004, to
describe quantitative and qualitative factors we use in establishing our
accruals as well as the sources of information we consider important, including
that from internal and external sources.
Although many of the individual assumptions we use in developing our
estimates are quantifiable, we have over 100 products none of which currently
represent more than 10% of the total product sales and attempting to provide
disclosure on a product-by-product basis would result in excessive detail that
may confuse investors and would de-emphasize the material information about how
the key reserves are actually determined, as noted in our response to 3.a. and
3.b. above.
In reaching this conclusion, we also considered the guidance in the
Commission's Interpretive Release No. 33-8350, Commission Guidance Regarding
Managements Discussion and Analysis of Financial Condition and Results of
Operations, which provides that "Disclosure should emphasize material
information that is required or promotes understanding and de-emphasize (or, if
appropriate, delete) immaterial information that is not required and does not
promote understanding." The Interpretive Release further provides that,
"Companies must determine, based on their own particular facts and
circumstances, whether disclosure of a particular matter is required by MD&A.
However, the effectiveness of MD&A decreases with
Mr. Jim B. Rosenberg
U.S. Securities and Exchange Commission
February 1, 2005
Page 4
the accumulation of unnecessary detail or duplicative or uninformative
disclosure that obscures material information."
D) 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.
RESPONSE: From time to time the Company provides incentives, such as trade show
allowances or stocking allowances, that provide incremental rebates to customers
who in turn use such incremental allowances to accelerate distribution to the
end customer. We believe that such incentives are normal and customary in the
industry. Additionally, we understand that certain of our wholesale customers
speculate about the timing of price increases and have made and may continue to
make business decisions to buy additional product in anticipation of future
price increases. This practice has been customary in the industry and would be
part of a customer's "ordinary course of business inventory level." If we were
to make shipments of inventory based on incentives that were not usual and
customary in the industry, or if we were to obtain knowledge of one of our
customers purchasing inventory from us that is outside the normal course of
their business inventory level, we will discuss such shipments, if material, and
their impact on our revenue recognition in MD&A.
E) 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 THE CURRENT PERIOD,
- CURRENT PROVISION RELATED TO SALES MADE IN PRIOR PERIODS,
- ACTUAL RETURNS OR CREDITS IN CURRENT PERIOD RELATED TO SALES
MADE IN THE CURRENT PERIOD,
- ACTUAL RETURNS OR CREDITS IN CURRENT PERIOD RELATED TO SALES
MADE IN PRIOR PERIODS, AND
- ENDING BALANCE.
RESPONSE: We believe that the most significant information we can provide
investors regarding our accruals is the nature of the accrual, the factors we
consider in developing our estimates and disclosing when changes in our
methodology or assumptions used in developing our estimates have a material
impact on our results. We respectfully submit that providing roll-forward
information on a quarterly basis would not be meaningful to investors, as that
concept is discussed in the Commission's Interpretive Release No. 33-8350 noted
above.
Mr. Jim B. Rosenberg
U.S. Securities and Exchange Commission
February 1, 2005
Page 5
F) IN YOUR DISCUSSION OF RESULTS OF OPERATIONS FOR THE PERIOD TO PERIOD
REVENUE COMPARISONS, DISCUSS THE AMOUNT OF AND THE REASON FOR
FLUCTUATIONS FOR EACH TYPE OF REDUCTION IN GROSS REVENUE, FOR
EXAMPLE, PRODUCT RETURNS, CHARGEBACKS, CUSTOMER REBATES AND OTHER
DISCOUNTS AND ALLOWANCES, INCLUDING THE EFFECT THAT CHANGES IN YOUR
ESTIMATES OF THESE ITEMS HAD ON YOUR REVENUE AND OPERATIONS.
RESPONSE: To help investors better understand the period-to-period comparisons
in our net revenues, we disclose the effects that material volume and net
pricing changes have had on the results presented.
Our existing disclosure regarding changes in net pricing is directly
related to our analysis of changes in the individual allowances that reduce
gross sales. In many instances, our disclosure about the reasons for changes in
net pricing are the same ones we would repeat if we provided disclosure on each
component. For example, changes in product mix, customer mix and new competition
can impact the amounts of our accruals for returns & allowances, chargebacks,
and rebates and, therefore, impact overall net pricing changes. In those cases,
where a significant change in an allowance that reduces gross sales has a
material impact on our results, we provide such disclosure in the context of our
discussion of changes in net pricing. For example, when shelf stock adjustments
due to the launch of a competing generic product are material, we disclose that.
Therefore, because we have and will continue to provide specific disclosure
about the impact on net revenues arising from a specific component of the
reserves when material, we respectfully submit that providing the detailed
discussion for each component of net sales would not provide investors with any
more meaningful information or promote an increased understanding of our
operating results.
INVENTORY RESERVES, PAGE 46
COMMENT 4. FOR EACH PRODUCT WHICH MANAGEMENT HAS CAPITALIZED A SIGNIFICANT
AMOUNT OF COSTS WITHOUT REGULATORY APPROVAL OR BEFORE SATISFACTORY RESOLUTION OF
PATENT INFRINGEMENT LITIGATION, PLEASE DISCLOSE THE FOLLOWING:
- THE CURRENT STATUS OF THE APPROVAL PROCESS, INCLUDING ANY
CONTINGENCIES NEEDED TO BE RESOLVED PRIOR TO OBTAINING FDA APPROVAL,
THE RISKS AFFECTING THE PROBABILITY OF OBTAINING FDA APPROVAL, AND
THE ESTIMATED TIMING OF OBTAINING APPROVAL.
- THE SPECIFIC NATURE OF ANY SAFETY AND EFFICACY, MANUFACTURING, AND
MARKETING OR LABELING ISSUES OUTSTANDING AND WHY THE COMPANY DOES
NOT BELIEVE THOSE ISSUES AFFECT ITS PROBABLE FUTURE BENEFITS
CONCLUSION.
- THE REMAINING SHELF LIFE OF EACH PRODUCT, AS OF EACH BALANCE SHEET
DATE PRESENTED, AND EXPIRATION OF THE SHELF LIFE.
Mr. Jim B. Rosenberg
U.S. Securities and Exchange Commission
February 1, 2005
Page 6
- THE RISKS AND UNCERTAINTIES SURROUNDING MARKET ACCEPTANCE OF THE
PRODUCT ONCE APPROVED AND HOW THIS WILL AFFECT THE REALIZATION OF
THE ASSET.
- THE CURRENT STATUS OF PRODUCT RELATED LITIGATION SUCH AS PATENT
INFRINGEMENT LAWSUITS AND THE NATURE OF ALL CONTRACTUAL RESTRICTIONS
THAT MUST BE SATISFIED PRIOR TO THE SALE OF THE PRODUCT, IF ANY.
INCLUDE WITHIN YOUR DISCLOSURE A ROBUST ANALYSIS OF THE EFFECT ANY
LAWSUIT AND/OR CONTRACTUAL RESTRICTIONS HAD OR WILL HAVE ON THEIR
INITIAL ASSESSMENT THAT AN ASSET EXISTED AS WELL AS THEIR ON-GOING
ASSESSMENT OF THE REALIZABILITY OF THE CAPITALIZED INVENTORY.
- THE EFFECT OF BUILD-UP OF PRE-LAUNCH INVENTORY BALANCES ON
LIQUIDITY.
RESPONSE: The amount of inventory for products awaiting regulatory approval or
pending the resolution of patent infringement litigation at September 30, 2004
and June 30, 2004 was $10.2 million and $4.5 million, respectively, based on
total current assets at September 30, 2004 and June 30, 2004 of $920 million and
$900 million, respectively. We do not consider this level of inventory material
for purposes of inclusion as one of our Critical Accounting Policies in MD&A. To
the extent it becomes material in the future, we will add disclosure in MD&A
about our accounting policies related to such inventory and disclose the amount
of such inventory.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
NOTE 1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
E. INVENTORIES
COMMENT 5. WE NOTE IN CERTAIN CIRCUMSTANCES YOU MAY COMMENCE THE MANUFACTURE AND
INVENTORY OF COMMERCIAL QUANTITIES OF PRODUCTS THAT HAVE NOT RECEIVED FINAL
REGULATORY APPROVAL OR SATISFACTORY RESOLUTION OF RELATED OUTSTANDING
LITIGATION. PLEASE EXPAND YOUR ACCOUNTING POLICY REGARDING CAPITALIZATION OF
UNAPPROVED PRODUCTS OR A PRODUCT IN LITIGATION, TO ADDRESS THE FOLLOWING:
- SPECIFICALLY STATE THE POINT DURING THE FDA APPROVAL PROCESS THAT
MANAGEMENT DETERMINES A FUTURE PROBABLE BENEFIT EXISTS.
- DISCLOSE THE STATUS OF THE FDA'S CONSIDERATION OF THE SAFETY AND
EFFICACY OF THE DRUG AND EVALUATION OF THE MANUFACTURING PROCESS AT
THAT POINT.
- FOR THE PRODUCTS THAT OUTSTANDING LITIGATION HAS NOT BEEN
SATISFACTORILY RESOLVED, STATE THE POINT DURING THE LITIGATION
PROCESS THAT MANAGEMENT DETERMINES A PROBABLE FUTURE BENEFIT EXISTS.
- DISCLOSE HOW THE LOWER OF COST OR MARKET PRINCIPLE IS APPLIED TO
PRE-LAUNCH INVENTORY. WE DO NOT BELIEVE IT IS APPROPRIATE TO
AGGREGATE PRE-LAUNCH INVENTORY
Mr. Jim B. Rosenberg
U.S. Securities and Exchange Commission
February 1, 2005
Page 7
WITH INVENTORY FOR COMMERCIAL SALE WHEN APPLYING THE LOWER OF COST
OR MARKET PRINCIPLE.
- PLEASE REVISE NOTE 6 TO SEPARATE PRE-LAUNCH INVENTORY FROM
COMMERCIAL INVENTORY AND SEPARATELY QUANTIFY THE TOTAL AMOUNT OF
INVENTORY BY CATEGORY, FOR EXAMPLE, RAW MATERIALS, WORK IN PROCESS
AND FINISHED GOODS, AND IN TOTAL FOR EACH.
RESPONSE: To the extent it becomes material in the future, we will discuss
pre-launch inventory in our Summary of Significant Accounting Policies in the
footnotes to our annual financial statements, as well as in the Summary of
Critical Accounting Policies in our MD&A, as noted in our response to question 4
above.
SUPPLEMENTAL DISCLOSURE
In addition, the Company hereby acknowledges the following:
- the Company is responsible for the adequacy and accuracy of
the disclosures in its filings with the Commission;
- Staff comments or changes to disclosures in response to Staff
comments in the filing reviewed by the Staff do not foreclose
the Commission from taking any action with respect to the
filing; and
- the Company may not assert Staff comments as a defense in any
proceeding initiated by the Commission or any person under the
federal securities laws of the United States.
* * * *
Mr. Jim B. Rosenberg
U.S. Securities and Exchange Commission
February 1, 2005
Page 8
Please direct any further comments or questions you may have to the
undersigned at (201) 930-3730 (phone), (201) 930-3330 (fax) or
bmckee@barrlabs.com.
Thank you.
Very truly yours,
William T. McKee
Vice President, Chief Financial
Officer and Treasurer
Barr Pharmaceuticals, Inc.
cc: Bruce L. Downey (Chief Executive Officer, Barr Pharmaceuticals, Inc.)
Frederick J. Killion (General Counsel, Barr Pharmaceuticals, Inc.)
George Stephan (Chairman of the Audit Committee, Barr Pharmaceuticals, Inc.)
Paul S. Krieger (Deloitte & Touche)
William M. Rustum (Gibson, Dunn & Crutcher LLP)