SEC Company Response from NOVAVAX INC (NVAX) (CIK 0001000694) (NVAX) — Jul 26, 2005
NOVAVAX INC (NVAX) (CIK 0001000694)
Date: July 26, 2005 · CIK: 0001000694 · Accession: 0000950133-05-003213
AI Filing Summary & Sentiment
File numbers found in text: 000-26770
Referenced dates: July 12, 2005
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CORRESP
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July 26, 2005
Via Facsimile and U.S. Mail
Jim B. Rosenberg, Senior Assistant Chief Accountant
Dana Hartz, Staff Accountant
Securities and Exchange Commission
Division of Corporation Finance
450 Fifth Street, N.W.
Washington, D.C. 20549
Re:
Novavax, Inc.
Form 10-K/A for the Fiscal Year Ended December 31, 2004
Filed March 15, 2005
File No. 000-26770
Dear Mr. Rosenberg and Ms. Hartz:
On behalf of Novavax, Inc. (the “Company”), I am writing to respond to the comments set forth
in your letter dated July 12, 2005 with respect to the above referenced filing (the “Filing”). For
your convenience we have repeated each of the comments in this letter. The Company’s responses are
set forth below each comment paragraph.
Management’s Discussion and Analysis
Liquidity and Capital Resources (page 29)
1.
Please tell us why interest payments on long-term debt are excluded from the
contractual obligations and commitments table. Please refer to section IV of Financial
Reporting Release 72.
Historically, we have only included the principal payments due on our long-term debt in the
contractual obligations and commitments table. The interest expense related to our debts has
historically been disclosed in the Overview section of Management’s Discussion and Analysis, the
Results of Operations analysis in the MD&A section, and/or the Notes to the Consolidated Financial
Statements. In the Filing, those discussions and disclosures were made on page 20 in the
“Developments in 2004” section, page 26 in our “Interest Income/Expense” comparison, and in “Note 7
- Long-term debt” on pages F-18 and F-19 in the Notes to the Consolidated Financial Statements.
Mr. Jim Rosenberg and Ms. Dana Hartz
Securities and Exchange Commission
July 26, 2005
Page 2
Following our current review of Financial Reporting Release 72, we agree in the future it
would be best to include those interest payments in the table. Therefore, in future filings we
will include all interest expense related to debts and contractual obligations in the contractual
obligations and commitments table.
Notes to Consolidated Financial Statements
Note 4. Product Agreements and Acquisitions (page F-15)
2.
Please provide us with the detailed calculation supporting the $2,514,000
intangible asset recorded. In addition tell us how this amount qualifies as an
intangible asset. Please include the specific authoritative literature used in
arriving at your conclusions.
In July 2004 Novavax and King Pharmaceuticals, Inc. agreed to terminate their Co-Promotion
Agreements, which were originally executed in December 2000. These agreements related to the
co-marketing and sale of two potential Novavax-developed products, ESTRASORB ®
and ANDROSORB ® , both of which were targeted for hormone replacement
in the field of women’s health. In connection with the termination of these agreements, in July
2004 we also redeemed $40 million of convertible notes issued by Novavax to King from 2000 to 2002.
King was willing to exit from the relationship, terminate the agreements and redeem the notes
because King had publicly announced its decision to exit the women’s health segment of its
business. The transactions resulted in:
•
Redemption of the King convertible notes and accrued interest thereon,
•
Return to Novavax of all worldwide rights for ESTRASORB and ANDROSORB, and
•
Payment by King to Novavax of its sales and marketing support obligations through the
end of 2004.
There were two agreements entered into to terminate the relationship, a Termination Agreement
and an Exchange Agreement. The total consideration to King and transaction costs to Novavax were:
• Cash payments, net of cash received
$
13,998,866
• Common Stock issued with a fair market value
$
18,123,000
• Transaction expenses
$
1,010,000
Total Consideration
$
33,131,866
Mr. Jim Rosenberg and Ms. Dana Hartz
Securities and Exchange Commission
July 26, 2005
Page 3
This total consideration was accounted for as follows:
• Redemption of convertible notes payable
$
40,000,000
• Gain on redemption of notes (see below)
$
(11,162,233
)
• Write off of balance sheet accounts related to
the initial King agreements and notes,
as well as pre-termination transactions
between the companies
$
1,779,797
• Allocation to ESTRASORB intangible asset
$
2,514,302
Total Allocation
$
33,131,866
Baker-Meekins, an independent business valuation firm, determined the fair market value of the
convertible notes payable at the time of the transaction to be $29,637,737, which resulted in the
gain on the redemption of $11,162,233. The Company determined the value of the common stock issued
to King based on the closing price of the common stock on the date of execution of the Termination
and Exchange Agreements. Therefore, following the allocation to the common stock, the convertible
notes and the write off of related balance sheet accounts, the final allocation was to the
ESTRASORB intangible of $2,514,000.
In summary, one result of these transactions was our reacquisition of the remaining worldwide
rights of ESTRASORB, which had been sold to King in 2000. In the intervening time period, the
value of these rights increased due to the Company’s receipt of final FDA approval for the sale of
ESTRASORB as a product. The intangible asset acquired in these transactions was consequently
recorded based on guidance found in paragraph 9 of SFAS 142, Goodwill and Other Intangible Assets
and paragraph 6 of SFAS 141, Business Combinations.
Note 6. Supplemental Financial Data
Sales Returns and Rebate Allowances (page F-17)
3.
We note that your roll-forwards of the sales return and rebate allowances do
not segregate the provision related to sales made in the current period from the
provision related to sales made in prior periods. Please tell us the amounts for each
period. If you are unable to distinguish activity between prior and current year
sales, please tell us how you can determine for any period-end, that the financial
statements are fairly stated, that no material errors were made and that you can
reasonably estimate these deductions. Please refer to paragraphs 6 and 8 from SFAS 48
and SAB Topic 13(A)(4)(b).
Mr. Jim Rosenberg and Ms. Dana Hartz
Securities and Exchange Commission
July 26, 2005
Page 4
All of our products for sale have expiration dates, typically two years post-production. For
those products sold to our distributors or sold by our distributors to retailers that have not been
purchased by the end user, the right of return exists at any time within six months of the
expiration date. In addition, we provide rebates to members of certain buying groups who
purchase from our distributors, to distributors that sell to their customers at prices
determined under a contract between their customer and us, and to state agencies that administer
various programs such as the federal Medicaid and Medicare programs.
In recognizing revenues and the corresponding estimates for returns and rebates, we review the
criteria set forth in paragraphs 6 and 8 of SFAS 48, Revenue Recognition When Right of Return
Exists. In connection with the Filing, as with past years, we performed a detailed analysis of
such criteria and concluded that each of the criteria had been met and reasonable estimates of
return amounts and rebates could be made. We have presented below a separate discussion of the
allowances for returns and rebates, as the circumstances for determining each differ.
Returns
We estimate the provision for returns based on each of the following conditions, assessed both
independently and in comparison to one another:
•
historical return trends,
•
distributor inventory levels,
•
product prescription data,
•
current sales levels, and
•
product expiration dates.
Each of these conditions, in turn, is impacted by generic competition, the life cycle of the
product, and the point at which generic competition enters such life cycle. Experience has shown
that as genericization of a product occurs, the life cycle of the product shortens, thereby
negatively affecting sales and distributor levels and eventually increasing product returns, as
discussed below.
An estimate for the return provision is recorded as a liability and a reduction in revenue
when we record the sale of the product. Returns of a product normally occur in the period between
six months before and six months after the product expiration date. Therefore, returns typically
occur 18 to 30 months after the product is produced. We regularly analyze the historical return
trends on an individual product basis, as well as changes in demand for the product and changes in
our competition to determine if the amount of the liability is adequate, resulting in a reasonable
and reliable estimate.
Mr. Jim Rosenberg and Ms. Dana Hartz
Securities and Exchange Commission
July 26, 2005
Page 5
During the early part of 2004, sales for one of our prenatal vitamin products were impacted
directly by the unexpected entry of a generic product, which occurred much earlier in our product’s
life cycle than historically experienced and resulted in a substantial reduction in 2004 sales. By
the third quarter of 2004, it became apparent that we would be experiencing
substantial returns on this product during the later part of 2004 through 2005, corresponding
directly with the product expiration dates of products sold in 2002 and 2003. Accordingly, we
adjusted our allowance for returns by $1.283 million during the third quarter of 2004 to reflect
this change in estimate, in accordance with SAB Topic 13(A)(4)(b). Of the $2.119 million provision
for sales return booked in 2004, $1.283 applied to 2002 and 2003 sales for this product. This
adjustment represented a non-recurring charge. Further adjustments were made throughout the year
for our other products that would have also applied to prior year sales, but these amounts were
immaterial and recorded in the normal course. Disclosure of this non-recurring charge was made
both in “Note 3, Summary of Significant Accounting Policies, Revenue Recognition and Allowances”
and in “Item 7, Management’s Discussion and Analysis of Financial Condition and Results of
Operation, Critical Accounting Policies and Changes to Accounting Policies.” In future Form 10-K
filings, we will expand our footnote disclosure to indicate significant adjustments to the
provision that applied to previous years, and the reasoning the estimate changed, if applicable.
Rebates
Our rebate amounts are based upon the volume of sales and by reference to a specific price for
a product. We estimate the amount of the rebate that will be paid and record the liability and a
reduction in revenue when we record the sale of the product. Settlement of the rebate generally
occurs from three to 12 months after the sale. The provision for rebates for any given year
correlates with the revenue for that same period. We regularly analyze the historical rebate
trends and make adjustments to the provision for changes in trends and terms of rebate programs in
accordance with SAB Topic 13(A)(4)(b). For the last three fiscal years ended December 31, 2004,
2003 and 2002, rebate payment trends have been consistent and any adjustments to the provision have
been immaterial.
Mr. Jim Rosenberg and Ms. Dana Hartz
Securities and Exchange Commission
July 26, 2005
Page 6
The Company acknowledges that (a) the Company is responsible for the adequacy and accuracy of
the disclosure in the Filing; (b) staff comments or changes to disclosure in response to staff
comments do not foreclose the Commission from taking action with respect to the Filing; and (c) 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.
Please do not hesitate to call me at (484) 913-1203 if you have any additional comments or
questions.
Yours sincerely,
/s/ Dennis W. Genge
Dennis W. Genge
Chief Financial Officer
cc: Nelson M. Sims