SEC Company Response from Bausch Health Companies Inc. (BHC) (CIK 0000885590) (BHC) — Nov 25, 2005
Bausch Health Companies Inc. (BHC) (CIK 0000885590)
Date: Nov. 25, 2005 · CIK: 0000885590 · Accession: 0001047469-05-027399
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File numbers found in text: 000-22358
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November 25, 2005
Mr. Jim
B. Rosenberg
Senior Assistant Chief Accountant
Division of Corporation Finance
United States Securities and Exchange Commission
Washington, D.C. 20549
Re:Biovail Corporation
Form 20-F for Fiscal Year Ended December 31, 2004
Form 6-K filed August 12, 2005
File No. 000-22358
Dear Mr. Rosenberg:
Biovail
Corporation (the "Company", "Biovail", "we", "us" or "our") acknowledges the receipt of the letter from the staff of the United States Securities and Exchange
Commission (the "Commission") dated September 30, 2005. Please find below our detailed responses to the staff's comments on our Form 20-F for the fiscal year
ended December 31, 2004 and Form 6-K filed August 12, 2005. For ease of reference, we have provided the text of each comment prior to our response.
Comment:
Where indicated, we think you should revise your Form 20-F for the year ended December 31, 2004. If you disagree, we will
consider your explanation as to why our comment is inapplicable or a revision is unnecessary.
Response:
The proposed amended disclosures to our Form 20-F for the fiscal year ended December 31, 2004, in response to staff comments
1 and 3 are set forth in this letter. In response to staff comments 2, 4, 6, 10, 12 and 13 we have proposed to include additional disclosure in our future filings,
beginning with our Form 20-F for the fiscal year ended December 31, 2005. In response to staff comments 5 and 7 we have noted that we do not believe that
additional disclosure is necessary.
1
Comment:
Form 20-F
for the Fiscal Year Ended December 31, 2004
Item 5. Operating and Financial Review and Prospects, page 56
MD&A in Accordance with U.S. GAAP, page 57
Critical Accounting Policies and Estimates, page 58
Revenue Recognition, page 59
1.We
noted that revenue from product sales is recognized net of provisions for estimated discounts and allowances, returns, rebates and chargebacks. In addition, we noted that a
significant change in the estimate of product returns could have a material impact on your results of operations. As we did not note the disclosures about these provisions contemplated by
Section V of Financial Reporting Release 72, please revise your disclosures to provide the following information:
a.The
nature and amount of each provision at each balance sheet date and the effect that could result from using other reasonably likely assumptions than what you used to arrive at each
provision, such as, in the form of, a range of reasonably likely amounts or other type of sensitivity analysis.
b.The
factors that you consider in estimating each provision, such as whether you use historical return of products, levels of inventory in the distribution channel, estimated shelf
life, price changes from competitors, and introductions of generics and/or new products.
c.The
extent to which you rely on information from external sources, such as, end-customer prescription demand or third-party market research data comparing wholesaler
inventory levels to end-customer demand.
d.For
returns, the total amount, in sales dollars, that could potentially be returned as of the balance sheet, in tabular format by product and by expiration period.
e.A
roll forward of each provision, for each period presented, showing the following:
•beginning
balance;
•current
period provision related to sales made in current period;
•current
period provision related to sales made in prior periods;
•actual
payments or credits in current period related to sales made in current period;
•actual
payments or credits in current period related to sales made in prior periods; and
•ending
balance.
f.The
amount and reason for period-to-period fluctuations in the amounts added to each provision, including the effect that changes in your estimates had on your
revenues and results of operations.
2
Response:
We will amend our disclosure of critical accounting policies and estimates related to revenue recognition in our Form 20-F for the
fiscal year ended December 31, 2004, as follows:
Revenue
recognition
We
recognize product sales revenue when title has transferred to the customer, provided that we have not retained any significant risks of ownership or future obligations with respect to the product
sold. Revenue from product sales is recognized net of provisions for estimated cash discounts, allowances, returns, rebates and chargebacks. We establish these provisions concurrently with the
recognition of product sales revenue. We continually monitor these provisions and evaluate the estimates used as additional information becomes available. We make adjustments to these provisions
periodically to reflect actual and future estimated experience. In connection with these provisions related to sales of products manufactured by us for distribution by our third-party licensees, we
rely on estimates made by these licensees.
Continuity of product sales provisions
The
following table displays a continuity of each of our product sales provisions:
Cash Discounts
Allowances
Returns
Rebates and Chargebacks
Total
($ in 000s)
Balance at January 1, 2002
2,227
945
18,302
8,698
30,172
Current year provision
8,148
1,099
22,716
34,834
66,797
Prior year provision
—
—
1,800
(1,900
)
(100
)
Payments or credits
(8,924
)
(1,770
)
(15,404
)
(26,344
)
(52,442
)
Balance at December 31, 2002
1,451
274
27,414
15,288
44,427
Current year provision
8,551
1,604
33,426
35,565
79,146
Prior year provision
—
—
28,122
(6,308
)
21,814
Payments or credits
(7,988
)
(1,428
)
(45,673
)
(23,394
)
(78,483
)
Balance at December 31, 2003
2,014
450
43,289
21,151
66,904
Current year provision
5,797
4,334
24,896
30,386
65,413
Prior year provision
—
—
14,062
(1,479
)
12,583
Payments or credits
(4,751
)
(2,576
)
(51,826
)
(39,857
)
(99,010
)
Balance at December 31, 2004
3,060
2,208
30,421
10,201
45,890
Use of information from external sources
We
use information from external sources to estimate our significant product sales provisions. We obtain prescription data for our products from IMS Health ("IMS"), an independent pharmaceutical
market research firm. We use this data to identify sales trends based on end-customer demand and to estimate inventory requirements. Prior to 2004, we also relied on data obtained from IMS
to estimate inventory levels in our distribution channels. Since 2004, IMS no longer provides this service. As a result, we are now obtaining this inventory pipeline data directly from our three major
wholesalers (which are Cardinal Health, Inc., McKesson Corporation and AmerisourceBergen Corporation). The inventory data received from these wholesalers excludes inventory held by customers to
whom they sell, such as retail pharmacies. In late 2004 and early 2005, we entered into fee-based distribution agreements with these wholesalers, which require these wholesalers to provide
us with more extensive data with respect to the sales and inventory levels of our products, such as inventory levels on-hand and on order, aggregate sales out and product returns, as well
as customer monitoring services to detect speculative buy activity by these wholesalers' customers.
3
The
information from external sources is provided to us in aggregate only and not by specific lot number, which is the level of detail that would be required to determine the original sale date and
remaining shelf life of inventory in our distribution channels. At December 31, 2004, our three major wholesalers maintained overall approximately two months worth of inventory of our products.
These wholesalers accounted for approximately two-thirds of our direct product sales in 2004. Based on these inventory levels and projected sales demand for our products, the collection of
lot information would have limited use in estimating our product sales provisions.
Cash discounts and allowances
We
offer cash discounts for prompt payment and allowances for volume purchases to customers. Provisions for cash discounts are estimated at the time of sale and recorded as direct reduction to
accounts receivable and revenue. At December 31, 2004 and 2003, reserves for cash discounts were $3.1 million and $2.0 million, respectively. Provisions for allowances are
recorded in accrued liabilities. At December 31, 2004 and 2003, accrued allowances were $2.2 million and $0.5 million, respectively. We estimate provisions for cash discounts and
allowances based on contractual sales terms with customers, an analysis of unpaid invoices and historical payment experience. Estimated cash discounts and allowances have historically been predictable
and less subjective, due to the limited number of assumptions involved, the consistency of historical experience and the fact that we generally settle these amounts within one month of incurring the
liability.
Returns
Consistent
with industry practice, we generally allow customers to return product within a specified period before and after its expiration date. Provisions for these returns are estimated based on
historical return and exchange levels, third-party data with respect to inventory levels in our distribution channels, and the estimated shelf life of our products (which range on average from
approximately 18 to 48 months). Although the introduction of additional generic and/or new product competition does not give our customers the right to return product outside of our
established policy, we do recognize that such competition could ultimately lead to increased returns. Our estimates of inventory in our distribution channels are subject to the inherent limitations of
estimates that rely on information from external sources, as certain third-party data may itself rely on estimates, and reflect other limitations.
4
At
December 31, 2004 and 2003, accrued product returns were $30.4 million and $43.3 million, respectively. In 2004, 2003 and 2002, provisions for product returns related to sales
made in the current year were $24.9 million, $33.4 million and $22.7 million, respectively, or 3%, 5% and 3%, respectively, of gross product sales. If our product returns accrual
rate as a percentage of gross product sales were to differ by 10% from our estimates, our provisions for product returns recorded in 2004, 2003 and 2002 would change by approximately
$2.5 million, $3.3 million and $2.3 million, respectively. The higher product returns accrual rate as a percentage of revenue in 2003, relative to 2004 and 2002, was due primarily
to higher inventory levels in our distribution channels that resulted from increased generic competition and investment buying by wholesalers. In 2004, our major wholesalers began to reduce these
inventory levels in anticipation of the transition to the fee-based distribution agreements, which generally establish limits on inventory levels owned by these wholesalers, and are
expected to moderate investment buying by these wholesalers that can result in sales fluctuations unrelated to end-customer demand. As a result, we were able to reduce our product returns
accrual rate in 2004, to reflect a lower risk of product expiration and overstocking.
In
situations where we become aware that product returns may be higher or lower than historical experience would indicate (for example, due to fluctuations in sales trends or changes in
inventory levels in our distribution channels), we analyze the situation and if the analysis indicates that those factors may result in higher or lower product expiration, we adjust our product
returns provision accordingly, taking into account the level of inventory in our distribution channels. We made adjustments to the product returns provision of $14.1 million,
$28.1 million and $1.8 million in 2004, 2003 and 2002, respectively. These adjustments generally related to sales made in prior years, as the shelf life of our products range from
18 to 48 months, and customers are not permitted to return product with more than six months of shelf life remaining.
The
adjustments made to the product returns provision in 2004 and 2003 were primarily related to sales of Teveten®, Vasotec® and Vaseretic® (which were acquired in
2002) and Cardizem® CD (which was acquired in 2000). In certain cases we were required to accept returns of these products related to sales made prior to our acquisition by the companies
from whom we had acquired these products. As we had not recorded the original product sales, we had no basis to estimate the amount of these returns. As a result, a portion of the adjustments to the
product returns provision in 2004 and 2003 were related to these returns based on actual experience.
5
During
2004, we received our first significant returns of Teveten®, Vasotec® and Vaseretic® related to sales that we had made of these products in 2003 and 2002.
During 2003, we began to receive significant returns of Cardizem® CD related to sales that we had made of this product in 2002 and 2001. We initially based our provisions for returns
related to these products on the historical experience rates of the companies from whom we acquired these products. As we developed our own historical experience, we adjusted those experience rates as
appropriate. We noted that the returns levels for these products were higher overall than the historical experience of the companies from whom we acquired these products would have indicated. These
relatively higher levels of returns reflected increasing generic competition for these products that resulted in lower prescription demand, as well as a higher than anticipated conversion of patients
from Cardizem® CD to Cardizem® LA (which was launched in April 2003). These factors resulted in increased product expiration due to higher levels of inventory in our
distribution channels.
Rebates and chargebacks
We
are subject to rebates on sales made under governmental and managed care pricing programs. Provisions for these rebates are estimated based on historical experience, contractual sales terms with
managed care organizations, and relevant statutes with respect to governmental pricing programs. The largest of these rebates are associated with sales covered by Medicaid. We participate in state
government-managed Medicaid programs, as well as certain other qualifying federal and state government programs whereby discounts and rebates are provided to participating government entities.
Medicaid rebates are typically billed up to six months after the product is shipped. As a result, a Medicaid rebate provision includes: an estimate of outstanding claims for end-customer
sales that occurred but for which the related claim has not been billed; and an estimate for future claims that will be made when inventory in our distribution channels is sold through to
end-customers. Our calculation also requires other estimates, such as estimates of sales mix, to determine which sales are subject to rebates and the amount of such rebates. Periodically,
we adjust the Medicaid rebate provision based on actual claims paid. Due to the delay in billing, adjustments to actual may incorporate revisions of this rebate provision for several periods.
Chargebacks
relate to our contractual agreements to sell products to group purchasing organizations and other indirect customers at contractual prices that are lower than the list prices we charge
wholesalers. When these group purchasing organizations or other indirect customers purchase our products through wholesalers at these reduced prices, the wholesaler charges us for the difference
between the prices they pay us and the prices they sold the products to the indirect customers.
At
December 31, 2004 and 2003, accrued rebates and chargebacks were $10.2 million and $21.2 million, respectively. In 2004, 2003 and 2002, provisions for rebates and chargebacks
related to