SEC Company Response from SAVIENT PHARMACEUTICALS INC (CIK 0000722104) — Nov 8, 2005
SAVIENT PHARMACEUTICALS INC (CIK 0000722104)
Date: Nov. 8, 2005 · CIK: 0000722104 · Accession: 0001125282-05-005763
AI Filing Summary & Sentiment
File numbers found in text: 000-15313
Referenced dates: September 20, 2005
Show Raw Text
CORRESP
1
filename1.htm
Savient -- Response
Philip K. Yachmetz
Senior Vice
President –
Corporate Strategy
& General Counsel
Tel: 732-565-4705
Fax: 732-418-9065
November 8, 2005
Via EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E., Mail Stop 6010
Washington, DC 20549
Attention: Mr. Jim Peklenk
Re:
SAVIENT PHARMACEUTICALS, INC.
Form 10-K for Fiscal Year Ended December 31, 2004
Filed March 31, 2005
Form 10-Q for the quarter ended March 31, 2005
Filed May 10, 2005
File No. 000-15313
Ladies and Gentlemen:
Savient Pharmaceuticals, Inc. (“Savient” or the “Company”), is in receipt of the comments of the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) set forth in
a letter dated September 20, 2005, from Mr. Jim B. Rosenberg, Senior Assistant Chief Accountant of the Commission. The comment letter relates to our Annual Report on Form 10-K for fiscal year ended December 31, 2004 (the “2004 Form 10-K”)
filed with the Commission on March 31, 2005 and our Quarterly Report on Form 10-Q for the quarter ended March 31, 2005 filed with the Commission on May 10, 2005.
For convenient reference, we have included below in italicized type each of the Staff’s comments set forth in the comment letter and have keyed our responses to the numbering of the comments and the headings used in the
comment letter.
We hereby advise you as follows:
Form 10-K for the Fiscal Year Ended December 31, 2004
Item 7. Management’s Discussion
And Analysis of Financial Condition And Results Of Operations,
page 36
Critical Accounting Policies and the Use of Estimates, page 37
Securities and Exchange Commission
November 8, 2005
Page 2
Revenue Recognition, page 38
1.
Please provide us the following information in disclosure-type format to help us evaluate the adequacy of your disclosure. Please disclose the nature and amounts of revenue dilution (e.g., from product
returns, inventory credits, discounts, promotional allowances, rebates, chargebacks, reimbursements relating to Medicaid and Medicare and other allowances) in your sales discussions, particularly for significant recent product launches. Your
critical accounting policy should explain how you assess returns of new products, levels of inventory in the distribution channel, estimated shelf life, price changes for competitors and generics and expected introductions of new products that may
result in larger than expected returns of current products. Discuss to what extent you consider information from external sources (e.g., end-customer prescription demand, third-party market research data comparing wholesaler inventory levels to
end-customer demand) to assist you in such critical estimates.
Please provide a rollforward of the
estimate account for each significant revenue dilution item that shows
the following: 1) beginning balance, 2) current provision related to
sales made in current period, 3) current provision related to sales made
in prior periods, 4) actual charges in current period related to sales
made in current period, 5) actual returns in current period related to
sales made in prior periods, 6) ending balance. If you are unable to
provide the above-noted rollforwards, please quantify the amount of changes
in estimates in subsequent periods or explicitly state that no material
revisions were recognized, if true.
Please provide, in disclosure-type
format, for each type of significant dilution from revenue, the following
information (preferably in tabular format) to accentuate management’s
review of significant dilution estimates:
•
The total amount (in sales dollars) by product in the distribution channel (i.e., at wholesalers) as of the balance sheet date, and disaggregated by period of original sale or shipment; also disclose how
management gathered such information (e.g., internal projections? Third-party surveys? Confirmation from wholesalers?),
•
To what extent management used the above-noted distribution channel information to estimate potential exposure for each type of significant revenue dilution, and
•
Discuss how product expiration and/or other relevant dilution reserve factors impacts the various dilution reserve estimates. Other factors might include estimated shelf life, price changes from competitors
and generics and expected introductions of new products that may result in larger than expected returns of current products.
Securities and Exchange Commission
November 8, 2005
Page
3
If applicable, provide in
disclosure-type format, any shipments made to wholesalers wherein such
shipments are as a result of incentives or in excess of the wholesaler’s
ordinary course of business inventory level. Discuss your revenue recognition
policy for such shipments.
Response:
As a preface to this response, the Company directs the Staff to its October 26, 2005 press release which disclosed that the Company is in the process of amending the 2004 Form 10-K to include restated financial statements as of
December 31, 2002, 2003, and 2004 and for the fiscal years then ended. The Company is also preparing to file an amendment to its Quarterly Report on Form 10-Q for the quarter ended March 31, 2005. The Company has determined that these restatements
are required as the result of an error made in connection with estimating product return and inventory reserves related to sales of the Company’s Oxandrin products. It has been determined that an error had occurred in these prior financial
periods due to an “oversight or misuse of facts that existed at the time the financial statements were prepared.”1 The error related to data that was known and knowable,
however management did not appropriately contemplate the data that was available when making its original reserve assessments. Therefore, in order to address the Commission’s questions, the Company presents information herein related to the
originally filed financial statements, information that was known and knowable at the time of the filings, and current information under ongoing evaluation in connection with our in-process restatements. We expect to file the above-referenced
amendments to our periodic filings on or about December 26, 2005. Therefore, all information provided herein related to such amendments and restatements is preliminary and thus is subject to change. In addition, this information has not been subject
to audit or review procedures.
* * * *
Information related to the Company’s product revenue recognition policy and product revenue dilution items is as follows:
1. - Product Revenue Recognition. Product sales are recognized when title to the product has transferred to the Company’s customers in accordance with the terms of the sale. The
Company’s policy is and always has been to recognize revenue in accordance with the Commission’s Staff Accounting Bulletin No. 101, “Revenue Recognition in Financial Statements” as amended by Staff Accounting Bulletin No. 104 (together, “SAB 104”), and FASB Statement No. 48 “Revenue Recognition When Right of Return Exists”
(“FAS 48”). SAB 104 states that revenue should not be recognized until it is realized or realizable and earned. Revenue is realized or realizable and earned when all of the following criteria are met:
1 In accordance with APB 20, Accounting Changes, paragraph 13.
Securities and Exchange Commission
November 8, 2005
Page 4
(1)
persuasive evidence of an arrangement exists;
(2)
delivery has occurred or services have been rendered;
(3)
the seller’s price to the buyer is fixed and determinable; and
(4)
collectibility is reasonably assured.2
FAS 48 states that revenue from
sales transactions where the buyer has the right to return the product
shall be recognized at the time of sale only if:
(1)
the seller’s price to the buyer is substantially fixed or determinable at the date of sale;
(2)
the buyer has paid the seller, or the buyer is obligated to pay the seller and the obligation is not contingent on resale of the product;
(3)
the buyer’s obligation to the seller would not be changed in the event of theft or physical destruction or damage of the product;
(4)
the buyer acquiring the product for resale has economic substance apart from that provided by the seller;
(5)
the seller does not have significant obligations for future performance to directly bring about resale of the product by the buyer; and
(6)
the amount of future returns can be reasonably estimated.3
FAS 48 provides further guidance
related to potential factors that may impair the ability of management
to make a reasonable estimate. These include:
(1)
the susceptibility of the product to significant external factors, such as technological obsolescence or changes in demand;
(2)
relatively long periods in which a particular product may be returned;
(3)
absence of historical experience with similar types of sales of similar products, or inability to apply such experience because of changing circumstances, for example, changes in the selling enterprise’s
marketing policies or relationships with its customers; and
(4)
absence of a large volume of relatively homogeneous transactions.4
SAB 104 also provides guidance
for determining if returns can be reasonably estimated; additional factors
that should be considered include:
(1)
significant increases in or excess levels of inventory in a distribution channel (sometimes referred to as channel stuffing);
(2)
lack of visibility into or the inability to determine or observe the levels of inventory in a distribution channel and the current level of sales to end users;
(3)
expected introductions of new products that may result in the technological obsolescence of and larger than expected returns of current products;
2 SAB
104, section 1, “Revenue recognition – general.”
3 FAS 48, paragraph 6.
4 FAS 48, paragraph 8.
Securities and Exchange Commission
November 8, 2005
Page 5
(4)
the significance of a particular distributor to the registrant’s (or a reporting segment’s) business, sales and marketing;
(5)
the newness of a product;
(6)
the introduction of competitors’ products with superior technology or greater expected market acceptance; and
(7)
other factors that affect market demand and changing trends in that demand for the registrant’s products.5
The Company’s net revenues represent total revenues less allowances for returns, Medicaid rebates, other government rebates, discounts, commissions, and distribution fees. A summary of the annual deductions taken from gross
product sales to arrive at net product sales, as previously filed in the 2004 Form 10-K and with placeholders for the restated balances, is as follows:
($ in thousands)
Year Ended December 31,
2002
2002
2003
2003
2004
2004
(As filed)
(Restated)
(As filed)
(Restated)
(As filed)
(Restated)
U.S. gross pharmaceutical product sales
$
76,121
$
84,544
$
71,095
Less: Allowances for returns
10
94
13,114
Allowances for Medicaid rebates
5,094
7,005
5,188
Allowances for other government rebates
2,665
2,704
1,486
Commercial discounts
273
1,788
1,699
Commissions
2,796
176
-
Distribution fees
4,092
2,870
1,033
U.S. pharmaceutical product sales, net
61,191
69,907
48,575
Global biologic product sales
28,570
27,793
23,411
Oral liquid pharmaceutical products
6,346
27,146
34,023
Product sales, net
$
96,107
$
124,846
$
106,009
2. - Allowance for returns. In the United States, the Company sells three commercial products as summarized below:
Product
Expiration period
(in years)
Launch date
Oxandrin 10mg
2
September 2002
Oxandrin 2.5mg
5
December 1995
Delatestryl
5
July 1975
Prior to 2003, the Company primarily
sold Oxandrin 2.5mg and Delatestryl in the United States through Accredo
Health Incorporated (“Accredo”) which had acquired Savient’s
original distributor, Gentiva Health
Services Corporation (“Gentiva”), in June 2002. Under the sales contract
with Gentiva, title to the product passed upon receipt with
the right to receive replacement product (as opposed to a full right of return)
for expired or damaged goods. In addition, the contract provided that the replacement
of expired product was to be based upon Gentiva’s management of all Savient
products on a first-in-first-out basis.
5 SAB 104, section 4b, “Estimates and changes in estimates.”
Securities and Exchange Commission
November 8, 2005
Page 6
In September 2002, in conjunction with its launch of Oxandrin 10mg, the Company began to change its method of distribution, adopting the more common industry practice of selling directly to drug wholesalers. Product was shipped to
each wholesaler and invoiced by the Company’s third-party fulfillment center. In all cases, contracts with wholesalers provided wholesalers the right to return any expired product for credit at the original purchase price.6 Accredo continued to sell product until it liquidated its inventory in March 2003. Starting in April 2003, the Company sold all of its products directly to wholesalers.
The error that has led to the Company’s impending restatements stems primarily from the launch of Oxandrin 10mg in September 2002. At that time, the Company’s historic product return experience for Oxandrin 2.5mg and
Delatestryl was insignificant ($10,000 in 2002 and $94,000 in 2003 against sales of $76.1 and $84.5 million during the corresponding periods) and therefore led to the consistent, but erroneous, conclusion that a return reserve would not be required
for Oxandrin 10mg. The consistency conclusion was borne from the fact that Oxandrin 10mg was merely a dosage variance7 on a product that the Company had been selling for years with
immaterial returns. However, in early 2004, the Company began receiving returns of Oxandrin 10mg, and to a lesser extent Oxandrin 2.5mg, which had reached the end of its shelf life. At that time, the Company determined that an adjustment would be
required to accrue for future returns. This return reserve adjustment was based, in part, on notifications received from customers advising the Company, through its third-party fulfillment center, of their intent to return product. The Company
subsequently determined that certain of those reported returns were in error in that actual units of product returned were significantly less than the amounts originally expected to be returned. The Company also has determined that in recording its
reserves for product returns and inventory it had failed to properly evaluate this data and the resulting impact on such reserves.
In conjunction with its restatement efforts, the Company has now reviewed the actual returns history related to each of its products. In addition, the Company has reviewed the information that was known and knowable prior to its
filing of its Annual Reports on Form 10-K for the fiscal years ended December 31, 2002, 2003 and 2004. The preliminary findings are as follows:
6
The
Company’s return policy allows product to be returned six months
prior to, and within a range of six to twelve months, depending upon
the arrangement terms,
after the
expiration date.
7
Either
dosage level may be prescribed for most indications. The daily average
consumption (DACON) of