SEC Company Response from ELAN CORP PLC (CIK 0000737572) — Aug 10, 2005
ELAN CORP PLC (CIK 0000737572)
Date: Aug. 10, 2005 · CIK: 0000737572 · Accession: 0000950162-05-000801
AI Filing Summary & Sentiment
Referenced dates: July 22, 2005
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Elan Corporation, plc
Treausry Building, Lower Grand Canal Street
Dublin 2, Ireland
T + 353 1 709-4000 F +353 1 709-4700
Mr. Jim B. Rosenberg
Senior Assistant Chief Accountant
Division of Corporation Finance
US Securities and Exchange Commission
450 Fifth Street, N.W.
Washington, D.C. 20549 USA
August 10, 2005
Re: Elan Corporation, plc
Annual Report on Form 20-F for Fiscal Year ended December 31, 2004
Filed April 11, 2005
File No. 1-13896
Dear Mr. Rosenberg:
We set forth below our responses to the Staff's comment letter, dated July
22, 2005, containing comments with respect to our Annual Report on Form 20-F for
the fiscal year ended December 31, 2004 (the "2004 Annual Report on Form 20-F").
The numbered paragraphs below correspond to the numbered comments set forth in
the Staff's letter. For your convenience, we have reproduced each comment from
the Staff's letter (in italics) immediately before our response.
As requested, we have provided our response to the Staff's comment No. 1 in
disclosure-type format rather than keying our response to each of the Staff's
comments 1(a) through 1(f) individually. However, our response does address each
of the subcomponents of the Staff's comment No. 1. In addition, we plan to file
an amendment to our 2004 Annual Report on Form 20-F to include the revised
disclosure below.
1. Critical Accounting Policies, page 31 - Revenue - Discounts, Sales Returns,
Rebates and Chargebacks
We believe that your disclosure related to estimates of items that reduce gross
revenue such as product returns, chargebacks, customer rebates and other
discounts and allowances could be
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improved. Please provide us the following information, in disclosure-type
format, to help us evaluate the adequacy of your disclosure:
a) 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.
b) 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.
c) 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 (e.g., 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 potentially be returned as of the balance
sheet date and disaggregated by expiration period.
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.
e) 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
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* Ending balance.
f) Regarding 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, chargebacks,
customer rebates and other discounts and allowances) including the effect
that changes in your estimates of these items had on your revenues and
operations.
Elan's Response:
Revenue Recognition-Sales Discounts and Allowances
As described further below and in our significant accounting policies in Note 2
to the Consolidated Financial Statements, we recognize revenue on a gross
revenue basis and make various deductions to arrive at net revenue as reported
in the Consolidated Statement of Operations. These adjustments are referred to
as sales discounts and allowances and are described in detail below. Sales
discounts and allowances include charge-backs, managed health care and Medicaid
rebates, cash discounts, sales returns and other adjustments. Estimating these
sales discounts and allowances is complex and involves significant estimates and
judgments, and we use information from both internal and external sources to
generate reasonable and reliable estimates. We believe that we have used
reasonable judgments in assessing our estimates, and this is borne out by our
historical experience. At December 31, 2004, we had total reserves of $22.1
million for sales discounts and allowances, of which approximately 57% and 13%
related to Maxipime and Azactam, respectively. We have over six years'
experience in relation to these two products.
We do not conduct our sales using the consignment model. All of our product
sales transactions are based on normal and customary terms whereby title to the
product and substantially all of the risks and rewards transfer to the customer
upon either shipment or delivery. Furthermore, we do not have an incentive
program which would compensate a wholesaler for the costs of holding inventory
above normal inventory levels thereby encouraging wholesalers to hold excess
inventory.
Sales Discounts and Allowances
We account for sales discounts and allowances in accordance with EITF Issue No.
01-9, "Accounting for Consideration Given by a Vendor to a Customer (Including a
Reseller of the
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Vendor's Products)," and SFAS 48, "Revenue Recognition When Right of Return
Exists," as applicable.
The table below summarizes our sales discounts and allowances to adjust gross
revenue to net revenue for each significant category. An analysis of the
separate components of our revenue is set out in Note 3 of the Consolidated
Financial Statements.
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<CAPTION>
-----------------------------------------------
Years ended December 31,
-----------------------------------------------
2004 2003 2002
-----------------------------------------------
(US$ in millions)
<S> <C> <C> <C>
Gross revenue subject to
discounts and allowances 291.7 530.1 779.8
Contract manufacturing and
royalties 130.9 120.0 118.5
Contract revenue 77.3 98.9 350.7
Amortized revenue -
Adalat/Avinza 34.0 34.0 7.8
Co-promotion fees - - 62.8
---------- ---------- ----------
Gross revenue 533.9 783.0 1,319.6
---------- ---------- ----------
Sales discounts
and allowances:
Charge-backs (24.6) (27.1) (22.7)
Managed health care
rebates and other
contract discounts (5.1) (11.0) (21.3)
Medicaid rebates (8.2) (25.7) (51.3)
Cash discounts (5.6) (8.9) (38.1)
Sales returns (7.1) (24.6) (92.8)
Other adjustments (1.6) (0.1) (0.3)
---------- ---------- ----------
Total sales discounts
and allowances (52.2) (97.4) (226.5)
---------- ---------- ----------
Net revenue subject to
discounts and allowances 239.5 432.7 553.3
Contract manufacturing
and royalties 130.9 120.0 118.5
Contract revenue 77.3 98.9 350.7
Amortized revenue
- Adalat/Avinza 34.0 34.0 7.8
Co-promotion fees - - 62.8
---------- ---------- ----------
Net revenue 481.7 685.6 1,093.1
---------- ---------- ----------
---------- ---------- ----------
</TABLE>
Total sales discounts and allowances have decreased from 29.0% of gross revenue
subject to discounts and allowances in 2002 to 18.4% in 2003, and to 17.9% in
2004, as detailed in the rollforward below and as further explained in the
following paragraphs.
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Charge-backs increased as a percentage of gross revenue subject to discounts and
allowances from 2.9% in 2002 to 5.1% in 2003, and to 8.4% in 2004. The increase
is due primarily to changes in the product mix. Several of our divested products
were sold through retail pharmacies (principally Skelaxin, Zonegran and Sonata)
and therefore had lower levels of charge-backs in comparison to our retained
products.
The reductions in managed health care and Medicaid rebates as a percentage of
gross revenue subject to discounts and allowances from year to year are due
principally to changes in the product mix. Several of our divested products
(principally Skelaxin, Zonegran and Zanaflex) were sold through retail
pharmacies and therefore had larger components subject to managed health care
and Medicaid rebates. Consequently, due primarily to the divestment of these
products, the managed health care and Medicaid rebates as a percentage of gross
revenue subject to discounts and allowances have declined from 2.7% and 6.6%,
respectively, in 2002, to 2.1% and 4.8% in 2003, and to 1.7% and 2.8% in 2004.
Cash discounts as a percentage of gross revenue subject to discounts and
allowances decreased from 4.9% in 2002 to 1.7% in 2003, and to 1.9% in 2004. The
decrease is due principally to a change in our discounting strategy during 2002
as we concentrated on improving margins at the expense of volumes for certain of
our key product lines.
Sales returns as a percentage of gross revenue subject to discounts and
allowances decreased from 11.9% in 2002 to 4.6% in 2003, and to 2.4% in 2004 due
to a number of factors, primarily the genericization of a number of our products
in 2002 (principally Zanaflex), which increased the provision for returns in
that year, and changes in the product mix as a result of product divestments.
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The following table sets forth the activities and ending balances of each
significant category of adjustments for the sales discounts and allowances (US$
in millions):
<TABLE>
<CAPTION>
Managed
Health Care
Rebates and
Other
Charge- Contract Medicaid Cash Sales Other
back Discounts Rebates Discounts Returns Adjustments Total
------- ----------- -------- --------- ------- ----------- ---------
<S> <C> <C> <C> <C> <C> <C> <C>
Balance at
December 31, 2002 $ 7.2 $ 11.2 $ 8.0 $ 1.9 $ 72.9 $ 0.5 $ 121.7
Provision related to
sales made in
current period 27.3 11.0 25.7 8.9 17.6 0.1 90.6
Provision related to
sales made in
prior periods (0.2) -- -- -- 7.0 -- 6.8
Returns and payments (25.7) (20.4) (34.4) (9.5) (68.0) (0.6) (158.6)
Divestments 0.1 3.1 2.5 -- (1.0) -- 4.7
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Balance at
December 31, 2003 8.7 4.9 21.8 1.3 28.5 -- 65.2
Provision related to sales
made in current period 24.4 5.1 8.6 5.6 6.8 1.6 52.1
Provision related to sales
made in prior periods 0.2 -- (0.4) -- 0.3 -- 0.1
Returns and payments (24.2) (6.8) (23.9) (6.5) (19.8) (0.7) (81.9)
Divestments (0.2) (1.1) (4.4) -- (7.2) (0.5) (13.4)
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Balance at
December 31, 2004 $ 8.9 $ 2.1 $ 1.7 $ 0.4 $ 8.6 $ 0.4 $ 22.1
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Charge-backs
In the U.S., we participate in charge-back programs with a number of entities,
principally the U.S. Department of Defense, the U.S. Department of Veterans
Affairs, Group Purchasing Organizations and other parties whereby pricing on
products is extended below wholesaler's list price to participating entities.
These entities purchase products through wholesalers at the lower negotiated
price, and the wholesalers charge the difference between their acquisition cost
and the lower negotiated price back to us. We account for charge-backs by
reducing accounts receivable in an amount equal to our estimate of charge-back
claims attributable to a sale. We determine our estimate of the charge-backs
primarily based on historical experience on a product-by-product and program
basis, and current contract prices under the charge-back programs. We consider
vendor payments, estimated levels of inventory in the distribution channel, and
our claim processing time lag and adjust accounts receivable and revenue
periodically throughout each year to reflect actual and future estimated
experience.
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As described above, there are a number of factors involved in estimating the
accrual for charge-backs, but the principal factor relates to our estimate of
the levels of inventory in the distribution channel. At December