Via Facsimile and U.S. Mail
Mail Stop 6010
December 14, 2005
Ms. Diane M. Barrett
Vice President & Chief Financial Officer
Noven Pharmaceuticals, Inc.
11960 S.W. 144th Street
Miami, Florida 33186
Re: Noven Pharmaceuticals, Inc.
Form 10-K for Fiscal Year Ended December 31, 2004
File No. 0-17254
Dear Ms. Barrett:
We have limited our review of your filings to those issues
we
have addressed in our comments. In our comments, we ask you to
provide us with more information so we may better understand your
disclosure. After reviewing this information, we may raise
additional comments.
Please understand that the purpose of our review process is
to
assist you in your compliance with the applicable disclosure
requirements and to enhance the overall disclosure in your
filings.
We look forward to working with you in these respects. We welcome
any questions you may have about our comments or any other aspect
of
our review. Feel free to call us at the telephone numbers listed
at
the end of this letter.
2004 Form 10-K, filed March 16, 2005
Item 7. Management`s Discussion and Analysis of Financial
Condition
and Results of Operations
Critical Accounting Estimates
Revenue Recognition, page 45
1. We believe your disclosure, and corresponding disclosures
within
the financial statements of Novogyne, related to estimates of
items
that reduce gross revenue such as product returns, chargebacks,
customer rebates and other discounts and allowances could be
improved. Please provide us the following in disclosure-type
format:
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) To the extent that information you consider in estimating each
accrual is quantifiable, discuss 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 be potentially be returned as of the balance
sheet date and disaggregated by expiration period.
c) 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.
d) Your product return policy as it relates to your sales to
wholesale distributors, hospitals, clinics, and retail pharmacies.
e) A roll forward of the liability for each estimate for each
period
presented showing the following:
a. Beginning balance,
b. Current provision related to sales made in current period,
c. Current provision related to sales made in prior periods,
d. Actual returns or credits in current period related to sales
made
in current period,
e. Actual returns or credits in current period related to sales
made
in prior periods, and
f. Ending balance.
f) A discussion of the period to period comparisons of 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.
Inventories, page 48
2. For inventories of Noven`s generic fentanyl patch, which
management has capitalized prior to obtaining FDA approval, please
provide the following in disclosure-type format:
* The current status of the approval process at the balance sheet
date 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 benefit
conclusion.
* The remaining shelf life of each product, as of each balance
sheet
date presented, and why the Company believes it will be able to
realize the inventory prior to the expiration of the shelf life.
* The risks and uncertainties surrounding market acceptance of the
product once approved and how this will effect 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.
Management should include within that 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 ongoing assessment of the realizability of the capitalized
inventory.
* The effects of build-up of pre-launch inventory balances on
liquidity.
Financial Statements
Statements of Operations, page 82
3. Please tell us how you have complied with Item 4-08(k) and Item
5-
03(b)2 of Regulation S-X as you do not disclose separately the
costs
of product revenues generated from a related party.
Statements of Cash Flows, page 84
4. Please tell us how you have complied with SFAS 95 as it would
appear the distributions received from Novogyne would be
considered
an investing activity.
Notes to Financial Statements
2. Summary of Significant Accounting Policies
Inventories, page 86
5. Please provide to us, in disclosure-type format, a description
of
the accounting policy regarding capitalization of unapproved
products, which specifically states the point during the FDA
approval
process that management determines a probable future benefit
exists.
Specifically address whether management uses the lower of cost or
market principle applied to inventory taken as a whole or is
separately evaluated.
6. Please provide us in disclosure-type format a breakdown of the
$10.8 million in inventories capitalized prior to obtaining FDA
approval between finished goods, work in process, and raw
materials.
5. Contract and License Agreements
Shire Collaboration, page 96
7. Please tell us how the deferral of direct costs incurred in
pursuit of approval of your methylphenidate patch and recognition
of
these costs against a portion of the $25 million deferred revenue
previously received complies with GAAP. Please cite the
appropriate
literature management relied upon. Additionally, please support
the
current presentation within your Statements of Cash Flows of the
changes in these costs within operating activities.
Vivelle Ventures LLC
Statement of Operations, page 116
8. We note that you do not include amortization of the marketing
rights of the CombiPatch within costs of sales. Please tell us
how
you have complied with SAB Topic 11:B. Acceptable alternatives
are
classification of amortization amount with costs of sales or
expanding the cost of sales caption to include parenthetical
disclosure indicating that amortization is excluded and the amount
of
amortization excluded from cost of services. You gross margin
discussion in MD&A should be consistent with this presentation.
In
this regard if you exclude amortization from cost of sales, the
MD&A
discussion should clearly state the nature and amount of the
amortization that is excluded.
Please respond to these comments within 10 business days or tell
us
when you will provide us with a response. Please furnish a letter
that keys your responses to our comments and provide the requested
information. Detailed letters greatly facilitate our review.
Please
file your letter on EDGAR under the form type label CORRESP.
We urge all persons who are responsible for the accuracy and
adequacy of the disclosure in the filing to be certain that the
filing includes all information required under the Securities
Exchange Act of 1934 and that they have provided all information
investors require for an informed investment decision. Since the
company and its management are in possession of all facts relating
to
a company`s disclosure, they are responsible for the accuracy and
adequacy of the disclosures they have made.
In connection with responding to our comments, please
provide,
in your letter, a statement from the company acknowledging that:
* the company is responsible for the adequacy and accuracy of the
disclosure in the filing;
* staff comments or changes to disclosure in response to staff
comments 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.
In addition, please be advised that the Division of
Enforcement
has access to all information you provide to the staff of the
Division of Corporation Finance in our review of your filing or in
response to our comments on your filing.
If you have any questions, please contact Kevin Woody, Branch
Chief, at (202) 551-3629. In this regard, do not hesitate to
contact
me, at (202) 551-3679.
Sincerely,
Jim B. Rosenberg
Senior Assistant Chief Accountant
??
??
??
??
Ms. Diane M. Barrett
Noven Pharmaceuticals, Inc.
December 14, 2005
Page 1