corresp
May 7, 2007
BY EDGAR AND HAND DELIVERY
Jeffrey P. Riedler
Assistant Director
U.S. Securities and Exchange Commission
100 F Street N.E.
Washington, D.C. 20549
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Re: |
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Sucampo Pharmaceuticals, Inc.
Registration Statement on Form S-l
File No. 333-135133 |
Dear Mr. Riedler:
On behalf of Sucampo Pharmaceuticals, Inc. (Sucampo or the Company), this letter responds
to comments made by members of the Staff in telephonic conversations with representatives of the
Company on April 30, 2007 and May 4, 2007. In these conversations, the Staff and the Company
representatives discussed the response letter addressed to you and dated April 26, 2007 (the Prior
Letter). The Company intends to file an amendment to the Registration Statement after the Staff
has had the opportunity to review this response letter.
1. The Staff asked for additional analysis of how the Company accounts for the reimbursement
of the specified medical marketing expenses under the Supplemental Agreement discussed in the Prior
Letter. In particular, the Staff questioned why the Company presents these reimbursements on a
net basis as opposed to a gross basis in light of the fact that the Company accounted for the other
deliverable under the Supplemental Agreement, which the Company regarded as a single unit of
accounting under EITF 00-21, on a gross basis.
The Company had originally presented these reimbursements on a net basis as a reduction in its
sales and marketing costs based on the guidance of EITF 99-19. The deliverable of the
miscellaneous marketing activities between Takeda and the Company and the various vendors was
initially viewed by the Company as an agency relationship based on the guidance of EITF 99-19.
This evaluation was based in part on the Companys view that this was an
immaterial revenue stream with a limited life (less than one year) and that this was a
conservative treatment for an item that arguably had both net and gross characteristics under the
guidance of EITF 99-19.
U.S. Securities and Exchange Commission
May 7, 2007
Page 2
In revisiting the guidance of EITF 00-21 related to the deliverables under the Supplemental
Agreement after inquiries from the Staff, the Company determined that there are two separate units
of accounting within the Supplemental Agreement: (1) the co-promotion activities related to its
sales force efforts and (2) the miscellaneous medical marketing activities. The Company deems
there is supportable evidence that there is value to Takeda on a stand-alone basis individually for
each of these services because Takeda could have obtained similar expertise and services by hiring
third parties to complete these activities, but relied instead on the Company to complete these
services.
The Company has also determined that there is objective and reliable evidence of the fair
value for each of these services. The Company contracted with third parties to complete all of the
required services. In addition, the Company relied on the work being performed by the third-party
vendors and concluded that its involvement with the services by the vendors did not add material
value to the services being provided to Takeda. Accordingly, the vendor costs incurred by the
Company for providing these services were determined to be objective and reliable evidence of the
fair value of each of the services in all material respects.
The Company also reevaluated the gross versus net presentation of the reimbursement payments
for each of these units of accounting using the guidance of EITF 99-19. In this reevaluation, the
Company did not identify any differences in the support for the presentation of revenue associated
with the co-promotion deliverable related to its sales force efforts on a gross basis, which was
documented in detail in response #51 in the response letter to the Staffs comments dated August
11, 2006. With respect to the miscellaneous medical marketing activities unit of accounting, the
following facts were determined by the Company to support the determination that the Company is
acting as a principal for this unit of accounting :
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The company is the primary obligor in the arrangement Although Sucampo is not
responsible for establishing the marketing publications strategy plan for AMITIZA,
it is specifically obligated to deliver medical marketing activities under this
plan. The selection of publication and total costs to complete the marketing
publications strategy plan are pre-approved by Takeda. In fulfilling its
obligation under this strategic plan, Sucampo specifically identifies vendors to be
engaged and is responsible to manage those vendors (which responsibility is not
differentiated from all other promotion activities which are obligations of and
controlled by Sucampo) |
U.S. Securities and Exchange Commission
May 7, 2007
Page 3
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The company has latitude in establishing price Sucampo negotiated the prices
with the vendors in advance of establishing the reimbursement amount when the
Supplemental Agreement was executed. |
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The company changes the product or performs part of the service Once a vendor
is engaged, Sucampo has discretion to oversee, review, and direct the scope of work
to be undertaken by the vendor to ensure that its obligations are properly
fulfilled. |
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The company has credit risk While the amount paid to the external supplier is
approved by Takeda, Sucampo makes the payments and carries the receivable related
to the reimbursement of the miscellaneous marketing expenses by Takeda and bears
credit risk of nonpayment by Takeda. |
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The company has discretion in supplier selection
The suppliers used in
completing the marketing publications strategy plan are initially proposed by
Sucampo. |
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The company is involved in the determination of product or service
specifications Sucampo, at its sole discretion, is responsible for managing the
parameters of the miscellaneous medical marketing activities in a manner it feels
is appropriate to meet the strategy approved by the JCC. |
Indicators within the guidance that were deemed not to be applicable because no inventory is
involved with this unit of accounting were:
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The company has general inventory. |
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The company has physical loss inventory. |
Therefore, the Company has now determined to present revenue associated with the medical
marketing activities unit of accounting as co-promotion revenue on a gross basis using its current
co-promotion revenue recognition policy, which is consistent with the current accounting treatment
for the co-promotion unit of accounting. This revenue recognition policy was discussed in the
Prior Letter.
In addition, the Company continues to believe the revenue related to the medical marketing
activities unit of accounting is immaterial to the 2006 consolidated financial statements.
U.S. Securities and Exchange Commission
May 7, 2007
Page 4
2. As the Staff recommended, the Company will clarify in Note 11 its basis for determining
that its participation in the Joint Steering Committee, the Joint Manufacturing Committee and the
Joint Commercialization Committee under the Takeda Agreement, as discussed in the Prior Letter, has
value to Takeda on a stand-alone basis. Specifically, the Company will include the following
language in Note 11:
The Company determined that its participation in the Joint Steering Committee, the Joint
Manufacturing Committee and the Joint Commercialization Committee has value to Takeda on a
stand-alone basis because the individual committee participants provided by the Company have
valuable expertise that the Company believes support the success of the Agreement. Takeda
could have obtained similar expertise by hiring independent consultants, but is relying
instead on the expertise of the Company.
3. As the Staff recommended, the Company will clarify its disclosure in Note 3 to distinguish
between the sources of collaboration revenue and research and development revenue. Specifically,
the Company will include the following language in Note 3:
The Takeda Agreement consists of the following key funding streams an up-front
payment, milestone payments, reimbursements of development costs and royalty payments. The
cash flows associated with the individual units of accounting from the Takeda Agreement are
recognized as revenue using a time-based model. Under this model, cash flow streams related
to each unit of accounting are recognized as revenue over the estimated performance period.
Upon receipt of cash payments, revenue is recognized to the extent the accumulated service
time, if any, has occurred. The remainder is deferred and recognized as revenue ratably
over the remaining estimated performance period. A change in the period of time expected to
complete the deliverable is accounted for as a change in estimate on a prospective basis.
Revenue is limited to amounts that are nonrefundable and that Takeda is contractually
obligated to pay to the Company.
Of the $20.0 million upfront payment the Company received from Takeda, the Company
deferred approximately $2.4 million associated with its obligation to participate in joint
committees with Takeda, as described more fully in Note 11, and is recognizing this amount
as collaboration revenue using the time-based model over the applicable performance period,
which is equivalent to the 16-year life of the Takeda Agreement. The Company is recognizing
the remaining $17.6 million of the upfront payment as research and development revenue using
the time-based model over the
performance period, which is the estimated development period for the Constipation and IBS-C
NDA submissions.
U.S. Securities and Exchange Commission
May 7, 2007
Page 5
The Company will also add additional disclosure to Note 11 to summarize the various cash
streams and related revenue recognition under the Takeda Agreement and the Supplemental Agreement
as follows:
The following table summarizes the cash streams and related revenue recognition under
the Takeda Agreement and the Supplemental Agreement:
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Revenue Recognized for Year Ended December 31, |
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Deferred Amount at |
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Cash Received |
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2004 |
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2005 |
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2006 |
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December 31, 2006 |
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Collaboration revenue |
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Up-front payment
attributable to the
joint steering,
manufacturing and
commercialization
committees |
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$ |
2,376,125 |
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$ |
24,496 |
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$ |
146,977 |
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$ |
146,977 |
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$ |
2,057,675 |
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Research and development
revenue |
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Up-front payment
remainder |
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$ |
17,623,875 |
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$ |
1,355,683 |
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$ |
8,134,096 |
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$ |
6,157,059 |
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$ |
1,977,037 |
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Development milestones |
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50,000,000 |
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16,153,846 |
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28,237,180 |
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5,608,974 |
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Reimbursement of
research and
development expenses |
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31,506,601 |
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1,482,337 |
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14,671,504 |
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11,987,377 |
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3,365,383 |
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Total |
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$ |
99,130,476 |
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$ |
2,838,020 |
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$ |
38,959,446 |
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$ |
46,381,616 |
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$ |
10,951,395 |
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Accounts Receivable at |
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December 31, 2006 |
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Product royalty revenue |
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$ |
4,561,242 |
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$ |
6,590,479 |
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$ |
2,029,237 |
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Co-promotion revenue |
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$ |
3,534,598 |
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$ |
4,242,997 |
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$ |
708,399 |
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U.S. Securities and Exchange Commission
May 7, 2007
Page 6
4. As the Staff recommended, the Company will clarify in Note 3 and in Note 11 how it
accounts for the reimbursement of the specified medical marketing expenses under the Supplemental
Agreement, as described in response No. 1 above. Specifically, the Company will include the
following language in Note 3:
The Supplemental Agreement consists of the following key funding streams:
reimbursements of co-promotion costs based upon a per-day rate and reimbursements of the
costs of miscellaneous marketing activities.
Reimbursements of co-promotion costs for its sales for efforts and reimbursements of
miscellaneous marketing costs under the Supplemental Agreement are recognized as revenue as
the related costs are incurred and Takeda becomes contractually obligated to pay the
amounts. Based on the guidance of EITF 99-19, the Company has determined that it is acting
as a principal as it relates to these activities under the Supplemental Agreement and, as
such, records reimbursements of these amounts as co-promotion revenue. For the year ended
December 31, 2006, the Company recognized approximately $4.2 million of co-promotion
revenue.
The Company will also include the following language in Note 11:
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The Company shall perform miscellaneous marketing activities for AMITIZA, which
will be fully reimbursed by Takeda. There is no defined performance period, but the
performance period will not extend beyond January 31, 2007. The Company has recorded
approximately $779,000 of reimbursements of miscellaneous marketing costs for the year
ended December 31, 2006. This amount is recorded as co-promotion revenue in the
consolidated statements of operations and comprehensive (loss) income. |
5. As the Staff recommended, the Company will clarify the disclosure in Note 11 as to how it
made the determination that the deliverables under the Supplemental Agreement are economically
independent of those in the original Agreement, and thus should be treated as a single unit of
accounting separate from the original Agreement. Specifically, the Company will include the
following language in Note 11
The Company has determined that the required deliverables under the Supplemental
Agreement are economically independent of those in the original Agreement. The Company had
no obligations to perform any of the deliverables under the Supplemental Agreement at the
time the original Agreement was executed and the
U.S. Securities and Exchange Commission
May 7, 2007
Page 7
activities were not considered to be or contemplated as deliverables at that time.
Subsequent to the execution of the original Agreement, the Company agreed to perform
co-promotion and other marketing services for a fee that was negotiated at the time of the
Supplemental Agreement. The negotiated rates were determined to be market compensation for
services agreed to in the Supplemental Agreement based upon the stand-alone value of the
economics of the new obligations. Therefore, the Company views the deliverables under the
Supplemental Agreement as economically independent of those in the original Agreement.
The Company has assessed these required deliverables under the guidance of EITF 00-21
to determine which deliverables are considered separate units of accounting. The Company
was able to determine that its sales force has value to Takeda on a stand-alone basis
because the Company provided coverage in a market segment which could increase the sales of
AMITIZA. In negotiating the Supplemental Agreement, the Company established the fair value
for the per-day co-promotion rate using third-party evidence from contract sales
organizations. The Company has also determined that the miscellaneous marketing activities
have stand-alone value to Takeda separate from the Companys efforts to perform its
obligations to implement and maintain its sales force. These miscellaneous marketing
services, which related primarily to documenting and publicizing the medical benefits of the
product, could have been outsourced directly to a number of different third parties (as the
Company ultimately did), performed by Takeda staff or eliminated entirely if not judged to
have a benefit which exceeded the related costs. Accordingly, these deliverables are
treated as separate units of accounting. The Company is recognizing these cost
reimbursements received for these deliverables as co-promotion revenues when services are
performed and the reimbursement payments are due under the Supplemental Agreement. For the
year ended December 31, 2006, the Company recognized approximately $3.4 million of
co-promotion revenue for its sales force efforts and approximately $779,000 for its medical
marketing efforts.
* * * * *
The management of the Company has discussed the matters above with PricewaterhouseCoopers LLP,
the Companys independent registered public accountants, who concur that the Companys conclusions
are acceptable.
U.S. Securities and Exchange Commission
May 7, 2007
Page 8
If you have any questions or comments on the above, please contact me at (202) 663-6224.
Respectfully,
/s/
Brent B. Siler
Brent B. Siler
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cc: |
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Ms. Sonia Barros
Ms. Christine Allen
Mr. Kevin Woody
Mr. Mark Barrysmith
Securities and Exchange Commission
Sachiko Kuno, Ph.D
Ryuji Ueno, M.D., Ph.D., Ph.D.
Mr. Ron Kaiser
Ms. Mariam Morris
Jeffrey D. Karpf, Esq. |