corresp
March 29, 2007
Breat B. Siler
+1 202 663 6224 (f)
+1 202 663 6363 (f)
brent.siler@wilmerhale.com
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 the comment in your letter dated November 27, 2006 to Sachiko Kuno, the President and Chair of
the Board of Directors of Sucampo, regarding the filing of Amendment No. 4 to the Registration
Statement on Form S-1 (the Registration Statement). The Company originally responded to your
November 27, 2006 comment in a letter addressed to you and dated December 15, 2006. Based on
several telephonic conversations with various members of the Staff since that date, and at the
suggestion of the Staff, the Company is today revising its response to your original comment. We
have reproduced the original comment below for your convenience. As discussed with the Staff, the
Company intends to file an amendment to the Registration Statement after the Staff has had the
opportunity to review this revised response, which would include (1) restated financial statements
for the years ended December 31, 2004 and 2005 reflecting the revised accounting treatment
described in the response below, including revised footnote disclosure, and (2) financial
statements for the year ended December 31, 2006 reflecting the revised accounting treatment.
ORIGINAL STAFF COMMENT:
Financial Statements
Note 11. Collaboration and License Agreements, page F-26
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1. |
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We have reviewed your response to our previous comment number 13 and the collaboration
and License Agreement included as Exhibit 10.21. Please revise your |
Wilmer
Cutler Pickering Hale and Dorr
llp, 1875 Pennsylvania Avenue NW, Washington, DC 20006
Baltimore Beijing Berlin Boston Brussels London Munich New York Northern Virginia Oxford Palo Alto Waltham Washington
U.S. Securities and Exchange Commission
March 29, 2007
Page 2
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disclosure of the
Agreement with Takeda to include a description of all your rights and obligations, the
performance period, all deliverables, and the contractual cash flows as stipulated within
the agreement. Please identify each unit of accounting pursuant to EITF 00-21, the revenue
recognition method you employ for each unit, and the basis for using each revenue
recognition method. Please tell us and disclose if you have bundled several deliverables
into one single unit of accounting and how management determined the revenue recognition
model to be used for this single unit of accounting. Lastly, it appears that there is an
obligation of management to participate in several committees defined within the Agreement
without a specifically associated cash flow stream. Please tell us and disclose how you
have incorporated what appears to be an obligation of the company into your EITF 00-21
analysis. |
REVISED RESPONSE:
Background
On October 29, 2004, Sucampo Pharmaceuticals, Inc. (Sucampo or the Company) and Takeda
Pharmaceutical Company Limited (Takeda) entered into a Collaboration and License Agreement (the
Agreement), which was filed as Exhibit 10.21 to the Registration Statement. The purpose of this
Agreement was for the two parties to co-develop, commercialize, and sell products for
gastroenterology indications (Products) in the United States and Canada. The Products are
pharmaceutical drugs that contain the compound SPI-0211, or lubiprostone. Amitiza, the only
Product to date, was approved by the United States Food and Drug Administration (the FDA) for the
treatment of chronic idiopathic constipation (Constipation) in January 2006. A second indication
for Amitiza for the treatment of irritable bowel syndrome with constipation (C-IBS) continues to
be developed. Prior to the execution of the Agreement, the Company had been in the process of
developing SPI-0211 for both the Constipation and the C-IBS indications. At the time the Agreement
was signed, the Company had completed Phase III trials for the Constipation indication and was in
the process of initiating a Phase III trial for the C-IBS indication. The Agreement also
contemplated that the Company and Takeda could subsequently jointly agree to pursue the development
and commercialization of additional indications in the U.S. and Canadian gastroenterology market.
The term of the Agreement is from October 29, 2004 through December 31, 2020, unless
terminated earlier. The Agreement is terminable for the following reasons:
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A material breach of obligations by either party; |
U.S. Securities and Exchange Commission
March 29, 2007
Page 3
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A change of control of either party occurs, unless the change of control party
confirms its agreement to comply with its obligations in the Agreement; |
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A change of control of Takeda occurs and the surviving entity is developing or
marketing a product that competes with Sucampo Products; |
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A bankruptcy, insolvency or similar event of either party; |
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Sucampo may terminate if Takeda fails to achieve specified net sales revenue
targets; and |
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If a New Drug Application (NDA) approval for C-IBS cannot be obtained in the
United States, the parties will negotiate in good faith whether to continue future
development and commercialization of Products. If the parties cannot agree, then
either party will have the right to terminate. |
The effect of termination is as follows:
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Takeda is not required to make additional payments for which services have not yet
been rendered or which are not due to Sucampo as of the termination date; and |
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The licenses granted to Takeda will terminate and the related rights will revert to
Sucampo. |
The Agreement includes several deliverables that Sucampo is responsible to complete and Takeda
is responsible to fund. The following table summarizes the key deliverables by Sucampo within the
Agreement as of its execution on October 29, 2004:
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Deliverable |
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(with related |
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Agreement |
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Performance |
sections) |
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Contractual Cash Flows |
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Sucampo Obligations |
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Period |
License of the
compound SPI-
0211 to Takeda
(2.1)
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There are no defined contractual
cash flows for the grant of the
license to Takeda.
If Sucampo achieves
commercialization of Products,
Takeda shall, for the Products
sold during the term of the
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Sucampo shall provide
Takeda with an
exclusive license to co-
develop, use, sell,
promote, offer for sale,
import and distribute
the Products during the
Agreement period.
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The license was
granted upon
execution of the
Agreement in
October 2004 and
will expire when
the Agreement
expires in 2020 or |
U.S. Securities and Exchange Commission
March 29, 2007
Page 4
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Deliverable |
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(with related |
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Agreement |
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Performance |
sections) |
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Contractual Cash Flows |
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Sucampo Obligations |
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Period |
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Agreement, pay Sucampo royalties
on net sales. The level of
royalty payments is tiered based
on the level of net sales revenue
earned by Takeda.
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when it is earlier
terminated.
Royalty payments,
which Sucampo began
to receive in July
2006, will cease
when the Agreement
is terminated
(except with
respect to unsold
inventory) and all
cash payments due
to Sucampo are
paid. |
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Development for
NDA submission
for Constipation
and C-IBS (4.2(i)
and 7.2).
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Takeda shall fund the initial $30
million of development costs,
after which Sucampo shall fund
the next $20 million and the
parties shall equally share any
required funding in excess of
$50 million.
Takeda shall pay Sucampo non-
refundable milestone payments
for the Products upon certain
development events as related to
specific indications. 1
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Sucampo shall conduct
all development work
necessary for an NDA
submission (in the
United States and
Canada) for
Constipation and C-
IBS.
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There was no
defined
performance
period inherent in
the Agreement,
however as of
October 29, 2004
the Company
estimated that it
would complete
the research &
development in
December 2006.
An NDA for
Amitiza (for
Constipation) was
submitted in
March 2005 and
approved by the
FDA in January
2006.
During the second
quarter of 2006,
the Company
estimated that the
NDA submission
for C-IBS would
be completed in
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U.S. Securities and Exchange Commission
March 29, 2007
Page 5
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Deliverable |
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(with related |
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Agreement |
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Performance |
sections) |
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Contractual Cash Flows |
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Sucampo Obligations |
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Period |
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May 2007 and, as
of the date of this
letter, the
Company
estimates that the
completion will
be June 2007. |
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Participate in the
following
committees:
- - Joint Steering
Committee
(JSC)(3.1)
- - Joint
Development
Committee
(JDC)(4.1)
- - Joint
Commercialization
Committee
(JCC) (5.1)
- - Joint
Manufacturing
Committee
(JMC) (6.1)
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No separate cash flows were
established for these activities
at
the inception of the agreement.
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Sucampo agreed to
participate in the
committees during the
respective periods in
which each committee
was active
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There is no
defined
performance
period for each
committee. None
of the committees
will extend
beyond the term
of the Agreement.
The Company
expects
participation
within all
committees,
except the JDC, to
occur throughout
the Agreement
term. The
Company expects
participation in
JDC meetings to
continue only
while
development
activities are in
process. |
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1 |
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The following is a listing of the up-front payment and development milestone
events and the milestone and research and development payments that have been received
by Sucampo from Takeda after the occurrence of the applicable event through December
31, 2006. |
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Description |
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Payment (in millions) |
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Execution of Agreement |
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$ |
20 |
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NDA filing for Constipation |
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10 |
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Phase III entered for C-IBS |
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20 |
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NDA approved for Constipation |
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20 |
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Constipation and C-IBS research and development revenue |
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30 |
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$ |
100 |
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U.S. Securities and Exchange Commission
March 29, 2007
Page 6
As discussed in the table above, there are significant contractual cash payments,
including a nonrefundable up-front payment, nonrefundable milestone payments and reimbursements of
development costs owed to Sucampo upon completion of the associated deliverables. As of December
31, 2006, approximately two years after the Agreement was executed, the Company had received (a)
the $20 million nonrefundable up-front payment, (b) $50 million of nonrefundable milestone
payments, (c) $30 million of reimbursements of development costs, and (d) approximately $4.5
million of royalty payments on Takedas net sales of Amitiza.
Technical Accounting Research Considerations
The Company has performed the following steps in determining the appropriate accounting model
for its above mentioned deliverables and associated cash payments that Sucampo has received and
will receive from Takeda:
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1. |
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Consideration of the contract deliverables, pursuant to EITF 00-21, Revenue
Arrangements with Multiple Deliverables
(EITF 00-21), to determine whether separate
units of accounting exist; |
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2. |
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Selection of an accounting model for revenue recognition; and |
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Evaluation of EITF 99-19, Reporting Revenue Gross as a Principal versus Net as
an Agent (EITF 99-19), and EITF 01-14, Income Statement Characterization of
Reimbursements Received for Out of Pocket Expenses Incurred (EITF 01-14), to
determine the appropriate presentation of certain revenue streams. |
Step 1 Identification of deliverables and evaluation of EITF 00-21:
As discussed in the previous chart, at the time of its original execution, the Agreement
included multiple deliverables that the Company was responsible to perform. The original
assessment of EITF 00-21 by the Company resulted in a single unit of accounting for the
deliverables within the Agreement, including the participation in the committees. As of December
31, 2006, the Company re-assessed each deliverable using the guidance of EITF 00-21 to determine
which deliverables should be considered as separate units of accounting.
The re-assessment identified four separate units of accounting: (1) the development of
Constipation and C-IBS in order to file an NDA for each indication, which also includes
participating in the JDC, (2) participation in the JCC, (3) participation in the JSC and (4)
U.S. Securities and Exchange Commission
March 29, 2007
Page 7
participation in the JMC. The evaluation of EITF 00-21 to determine the four separate units of
accounting is discussed in the following paragraph.
The Company has now determined stand-alone values for the participation in the three
identified committees (the JCC, JMC and JSC), which are not associated with development. The
Company was able to specifically identify stand-alone value for the participation in each meeting
of these committees, including anticipated expenses expected to be incurred to meet its
obligations, by obtaining objective and reliable evidence of the fair value of this deliverable in
the form of contract agreements between the Company and specialized consultants for other
development projects the Company is and has been involved with currently and in the past, and
applying that to the number of required meetings throughout the Agreement term. The Company is
not, however, able to distinguish the stand-alone value for participation in the JDC from its
obligations to perform research and development of Constipation and C-IBS because the participation
in the JDC was to occur concurrently with the development work. As a result, the recognition of
revenue of the residual amounts received from Takeda related to the development work under the
Agreement, after the attribution of amounts to the participation in the JCC, JSC and JMC, will be
associated with the combined requirement of the development work of Constipation and C-IBS and
participating in the JDC.
Step 2 Selection of accounting model:
In 2004, when the Agreement was executed and the Company began to receive payments from
Takeda, the Company attempted to determine a systematic and rational attribution pattern that was
representative of and faithful to the economic substance of the Agreement, but that would not
result in revenue being recognized at any time in excess of the accumulated amounts owed to the
Company from Takeda. The Company had originally recorded the cash payments from Takeda as revenue
using the substantive milestone method. The method is frequently used as industry practice by
other comparable companies with similar collaboration and license arrangements. Under the
substantive milestone method, revenue for the payment is recognized once the milestone is achieved,
SAB No. 104, Revenue Recognition (SAB 104) criteria are met and the following
substantive-milestone-method criteria are met:
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A substantive effort must be involved in achieving each milestone; |
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Milestone payments must be reasonable in relation to the effort expended; |
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A reasonable amount of time should pass between the up-front payment and the first
milestone as well as between successive milestones; |
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Risk should be considered; and |
U.S. Securities and Exchange Commission
March 29, 2007
Page 8
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All milestone payments in an agreement should be compared to the effort needed to
achieve the milestone with one another and with the up-front payment. |
If these criteria are not met, then that milestone payment is deemed to be non-substantive and
the related payment is recognized separately over the term of the deliverable period. Accordingly,
while there is a single unit of accounting, there are two different attribution models for revenue
recognition resulting from the application of the substantive milestone method one for
substantive milestones and one for all other amounts. One could argue the application of the
substantive milestone method conflicts with a literal application of EITF 00-21 (i.e., two revenue
attribution methods applied to one unit of accounting). The re-assessment by the Company to
literally apply EITF 00-21 and further analyze its use of the substantive milestone method resulted
in the Company concluding that one attribution model to recognize revenue should be applied against
each unit of accounting in this Agreement. Accordingly, the Company determined that the
substantive milestone method would not be appropriate.
The Company then evaluated two separate attribution models, the EITF 91-6 model and the
time-based model, in determining which revenue model would be more appropriate, considering the
specific economic substances of research and development activities and the respective earnings
processes associated with the funding arrangements from Takeda. The following summarizes the
results of the Companys assessment of these two models:
The EITF 91-6 model
The Company assessed the application of a revenue model similar to the guidance discussed in
EITF 91-6, Revenue Recognition of Long-Term Power Sales Contracts, which relates to accounting for
long-term power sales contracts. Under this model, revenue is recognized using the lesser of
non-refundable cash received or the result achieved using percentage-of-completion accounting using
cost of efforts. The Company determined that the EITF 91-6 model was not appropriate for the facts
and circumstances of the Agreement because the Company would not have been able to reasonably
estimate its costs for its research and development due to the significant amount of volatility in
its costs, FDA regulations, and reliance on third parties to complete studies.
The Time-Based Model
The Company also assessed a revenue model similar to the EITF 91-6 model, with the performance
period being the revenue-recognition driver instead of expenses. The Company has concluded that
this time-based model is appropriate and has determined to utilize this model
to recognize revenue under the Agreement. In applying this model, the Company made the following
assumptions for each unit of accounting:
U.S. Securities and Exchange Commission
March 29, 2007
Page 9
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The cash flow streams related to the unit of accounting are ratably recognized as
revenue over the estimated performance period. |
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Upon receipt of cash payments during the performance period, revenue is recognized to
the extent the accumulated service time has occurred. The remainder is deferred and
recognized ratably over the expected remainder of the performance period. |
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A change in the period of time expected to complete the deliverable is accounted for on
a prospective basis as a change in estimate through the remainder of performance period. |
The cash flow items for each unit of accounting will be deferred upon receipt and recognized
as revenue ratably over the respective service periods. The accumulated revenue recognized will at
no time exceed the accumulated amounts owed to the Company from Takeda.
The cash flow amounts received from Takeda through December 31, 2006 associated with each unit
of accounting are as follows:
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Participation in JCC 2
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$ |
675,568 |
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Participation in JSC 2
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$ |
1,273,485 |
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Participation in JMC 2
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$ |
427,071 |
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Development of Constipation and C-IBS 3
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$ |
97,623,876 |
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2 |
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The amount is based on estimated fair value of the undelivered services,
including anticipated expenses expected to be incurred to meet its obligations, when the Company
became required to participate in the meetings and is deferred as a separate component of the
up-front $20 million payment. |
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The amount is the remaining cash flows received from Takeda related to the required
undelivered services (development of Constipation and C-IBS and participation in the JDC),
including the residual amount totaling $17,623,876 of the up-front $20 million payment after
deferring the fair value of the three committee meetings. |
Step 3 Evaluation of EITF 99-19 and EITF 01-14:
The Company further evaluated the presentation of the cash flows received from Takeda on a
gross versus net basis in accordance with EITF 99-19. Based on the evaluation of the indicators
within this guidance, the Company determined that the cash payments from Takeda should be
recognized as revenue on a gross basis and reported as revenue in the consolidated statements of
operations. In particular, the Company deemed itself to be the principal of the Agreement because
it is the primary obligor under the Agreement since it is responsible for executing the development
plan. Additionally, the Company has complete supplier discretion,
the Company is involved in determining the service specifications, and the Company assumes
credit risk for all expenses incurred during the service periods. This is consistent with the
U.S. Securities and Exchange Commission
March 29, 2007
Page 10
responses to comments 50 and 51 in the Companys response letter to the Staff dated August 11,
2006.
Additionally, the consensus in EITF 01-14 reinforces the Companys assertion that
reimbursements received for out-of-pocket expenses incurred should be characterized as revenue.
Supplemental Agreement with Takeda
On August 18, 2005, Sucampo notified Takeda in writing that Sucampo believed Takeda was in
material breach of the Agreement and that the Agreement would be terminated if disputed actions
surrounding the marketing and co-promotion of the drug candidate, which had since become Amitiza,
could not be resolved. On February 1, 2006, the two parties settled the disputed items claimed by
the Company by entering into a supplemental agreement to the Agreement (the Supplemental
Agreement). The Supplemental Agreement was filed as Exhibit 10.25 to the Registration Statement.
The purpose of the Supplemental Agreement was to amend and clarify for both Sucampo and Takeda
their respective responsibilities for the co-promotion of Amitiza, specifically the
responsibilities and funding arrangements for other commercialization and marketing services to be
performed by Sucampo and Takeda. There were no monies paid by either party for the execution of
the Supplemental Agreement. The term of the Supplemental Agreement ends when the Agreement expires
or is terminated.
As previously noted, Amitiza was approved by the FDA in January 2006 for the treatment of
Constipation. The commercial launch of Amitiza began in April 2006.
The Supplemental Agreement includes several deliverables that Sucampo is responsible to
complete and Takeda is responsible to fund. The following table summarizes the key deliverables by
Sucampo under the Supplemental Agreement as of its execution on February 1, 2006:
U.S. Securities and Exchange Commission
March 29, 2007
Page 11
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Deliverable |
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(with related |
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Supplemental |
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Agreement |
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Performance |
section) |
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Contractual Cash Flows |
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Sucampo Obligations |
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Period |
Co-promote
Amitiza with
Takeda (5.4 (a) of
Agreement and 6.2
of Supplemental
Agreement)
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Takeda shall pay Sucampo a
specified amount per day per
Sucampos sales force
representative, but not to
exceed certain pre-defined
amounts.
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Sucampo shall employ a
sales force of
approximately 38
representatives to
supplement Takedas
sales activities.
The terms within the
Agreement for co-
promotion activities were
superseded by the
Supplemental Agreement.
The Agreement stated
Sucampo had the option
to employ sales
representatives. The
Supplemental Agreement
amended the Agreement
to state that Sucampo
shall employ
approximately 38 sales
representatives for such
purposes. Detailed plans
and strategies must be
approved by the JCC.
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60 months
following the first
date (April 2006)
that Sucampo
deployed sales
representatives. |
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Perform
miscellaneous
marketing
activities for
Amitiza (Article 3
of Supplemental
Agreement)
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Takeda shall reimburse
Sucampo for all approved
external costs incurred for
such
miscellaneous marketing
activities.
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Sucampo shall conduct all
miscellaneous marketing
activities as approved by
the JCC.
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There is no
defined
performance
period, but it will
not exceed the
term of the
Agreement. Such
marketing
activities are
expected to occur
throughout the
Agreement term. |
U.S. Securities and Exchange Commission
March 29, 2007
Page 12
The deliverables under the Supplemental Agreement are viewed as economically independent
of those in the Agreement. The Company will recognize the cost reimbursements received for these
deliverables as revenue when due under the Supplemental Agreement.
Additional Required Deliverables
In the second quarter of 2006, the Company and Takeda agreed to begin three new studies
related to funding arrangements discussed in both the Agreement and Supplemental Agreement. The
deliverables that Sucampo is responsible to complete and Takeda is primarily responsible to fund in
connection with these new studies are summarized in the following schedule:
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Deliverable |
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(with related |
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Agreement |
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Performance |
section) |
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Contractual Cash Flows |
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Sucampo Obligations |
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Period |
Changes to
labeling (4.2 (iii)
of Agreement)
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Takeda shall fund 70% of
labeling studies and Sucampo
shall fund the remaining 30%
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Sucampo shall conduct
all
studies required to
modify, change or expand
the labeling of Products
for Constipation and C-
IBS as approved by the
JCC.
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Sucampo
estimates that the
Renal/Hepatic
labeling studies
that were initiated
in August 2006
will be completed
in January 2008. |
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Perform Phase
IV studies (4.2
(vi) of Agreement
and 5.1 of
Supplemental
Agreement)
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Takeda shall fund all Phase IV
studies.
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The terms within the
Agreement for Phase IV
studies were superseded
by the Supplemental
Agreement. The
Agreement states Takeda
shall conduct all Phase
IV
studies. The
Supplemental Agreement
has amended the
Agreement to state that
Sucampo shall conduct
all
Phase IV studies
approved by the JCC.
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The Company has
begun incurring
development
expenses related to
its Phase IV
studies for the
Constipation
indication of
Amitiza, which are
estimated to be
completed in
January 2008. |
U.S. Securities and Exchange Commission
March 29, 2007
Page 13
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Deliverable |
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(with related |
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Agreement |
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Performance |
section) |
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Contractual Cash Flows |
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Sucampo Obligations |
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Period |
Development of
additional
indication (4.2
(iv))
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Per each additional indication,
Takeda shall fund all internal
and external development work
up to a maximum aggregate of
$50 million.
If development costs exceed these
amounts, Takeda and Sucampo shall
equally share such excess costs.
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Sucampo shall conduct
all
development of the
additional
indication(s) as
approved by the JCC.
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Sucampo has
recently begun
work on the first
additional
indication for
Amitiza, for the
treatment of
opioid-induced
bowel dysfunction
(OBD).
Development costs
are currently
estimated to
exceed $50
million for this
indication.
Sucampo has
begun incurring
development
expenses related to
its pivotal Phase
II/III OBD study,
for which
Sucampo expects
to file an IND in
early 2007. At the
time of its
agreement to
conduct these
additional
deliverables,
Sucampo
estimated that this
study would be
completed in June
2009. |
As noted in the previous table, upon joint agreement with Takeda through the JCC, the
Company became obligated to complete three deliverables in the second quarter of 2006 and began
work on these deliverables during the third quarter of 2006. These deliverables are viewed as
economically independent from the deliverables agreed to when the Agreement and the Supplemental
Agreement were executed. The Company was under no obligation to perform the three new studies
prior to the second quarter of 2006 when the two parties agreed on the studies. The Company
re-assessed each deliverable using the guidance of EITF 00-21 to determine which deliverables
should be considered as separate units of accounting. Consistent
with the Companys initial EITF 00-21 assessment of the Constipation and C-IBS deliverable,
U.S. Securities and Exchange Commission
March 29, 2007
Page 14
the Company was unable to obtain objective and reliable evidence of the fair value of the
undelivered studies. Accordingly, the Company has combined these three new required deliverables
as a single unit of accounting. Consistent with the discussion above, the Company has applied the
time-based model, by which the Company will ratably recognize this revenue over the estimated
performance period of the combined deliverables. The estimated completion date is June 2009.
The Company also re-assessed this revenue under EITF 99-19 and EITF 01-14 and concluded that
the Company is the principal with respect to these deliverables and revenues should be presented
gross.
Summary
The Company entered into the Agreement with Takeda in October 2004. The Company then
expected, and continues to expect, the Agreement and the Supplemental Agreement to be profitable,
particularly in light of receiving the up-front and milestone payments for development events and
payments for commercial events and the ongoing royalty revenue stream for the Amitiza sales.
The Company had originally identified the required deliverables as a single unit of accounting
and recognized such revenue under the substantive milestone method. The Company has reassessed all
of the deliverables when they became requirements for both the Agreement and Supplemental Agreement
pursuant to EITF 00-21 and the revenue recognition model to be applied to the separate units of
accounting. This re-assessment resulted in a different revenue model, a time-based model, to be
applied against multiple units of accounting. In reviewing and assessing SFAS 154, the Company
will restate its 2004 and 2005 consolidated financial statements to reflect a correction of an
error in the next amendment to the Registration Statement.
* * * * *
Proposed Revised Footnote Disclosures
In response to the Staffs comment, the Company has included the following proposed revised
footnote disclosures for the restatement of previously issued consolidated financial statements
(Note 2), revenue recognition (Note 3) and the details of the collaboration and license agreements
with Takeda (Note 11). The Company intends to include these revised footnotes to its consolidated
financial statements in an amendment to the Registration Statement after the
Staff has had the opportunity to review the proposed language. The Company also intends, at
U.S. Securities and Exchange Commission
March 29, 2007
Page 15
that time, to modify its Managements Discussion and Analysis section as appropriate to reflect
similar modifications.
Restatement of Previously Issued Consolidated Financial Statements (Note 2)
The Company has restated its previously issued consolidated financial statements and related
footnotes as of December 31, 2005 and for the years ended December 31, 2004 and 2005, as set forth
in these consolidated financial statements. The Company has restated its consolidated financial
statements to correct an error in accounting for the revenue recognition of the collaboration and
license agreements with Takeda. All amounts in these consolidated financial statements have been
updated to reflect this restatement.
Description of Errors
The Company identified an error at its operating company in the United States. This error
originated in the fourth quarter of 2004 and continued throughout 2005. The identification of this
error occurred as a result of the Company evaluating its assumptions under EITF 00-21, Revenue
Arrangements with Multiple Deliverables, in accounting for arrangements with multiple deliverables
that require significant judgment and estimates.
The Company reassessed the stand-alone value to Takeda when deliverables from the joint
collaboration and license agreement with Takeda became a requirement of the Company by examining
objective and reliable evidence of the fair value of the undelivered items. This re-assessment
determined that the previous assessment of a single unit of accounting for the deliverables from
the joint collaboration and license agreement with Takeda was not appropriate. In addition, the
Company determined that the substantive milestone method was not appropriate to account for the
cash payments received from Takeda related to the Company completing these required deliverables
and a time-based model would be more applicable to account for such cash payments from Takeda.
Accordingly, in the restated consolidated financial statements for the years ended December 31,
2004 and 2005, the Company reduced the milestone revenue and increased research and development
revenue. Total revenue increased by approximately $1.2 million for the year ended December 31,
2004 and decreased by approximately $6.8 million for the year ended December 31, 2005. In
addition, related deferred revenue increased by approximately $5.6 million at December 31, 2005.
The following tables present the effects of the restatement adjustments on the affected line
items in the previously reported consolidated statements of operations and comprehensive income for
the years ended December 31, 2004 and 2005 and consolidated balance sheet as of
December 31, 2005. The restatement adjustments did not affect the overall cash (used in)
U.S. Securities and Exchange Commission
March 29, 2007
Page 16
provided by operating, investing or financing activities or the effect of exchange rates on cash and cash
equivalents in the consolidated statements of cash flows for the years ended December 31, 2004 and
2005.
Impact on Consolidated Statements of Operations and Comprehensive Income Items
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, 2004 |
|
|
As Reported |
|
Adjustment |
|
Restatement |
Collaboration revenue |
|
$ |
|
|
|
$ |
24,496 |
|
|
$ |
24,496 |
|
Research and development revenue |
|
|
1,482,337 |
|
|
|
1,355,683 |
|
|
|
2,838,020 |
|
Contract revenue |
|
|
275,154 |
|
|
|
(206,186 |
) |
|
|
68,968 |
|
Total revenues and other income |
|
|
2,665,290 |
|
|
|
1,173,993 |
|
|
|
3,839,283 |
|
Loss from operations |
|
|
(19,597,510 |
) |
|
|
1,173,993 |
|
|
|
(18,423,517 |
) |
Loss before income taxes |
|
|
(19,653,674 |
) |
|
|
1,173,993 |
|
|
|
(18,479,681 |
) |
Net loss |
|
|
(19,653,674 |
) |
|
|
1,173,993 |
|
|
|
(18,479,681 |
) |
Basic net loss per share |
|
|
(5.12 |
) |
|
|
0.30 |
|
|
|
(4.82 |
) |
Diluted net loss per share |
|
|
(5.12 |
) |
|
|
0.30 |
|
|
|
(4.82 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
|
(19,666,782 |
) |
|
|
1,173,993 |
|
|
|
(18,492,789 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, 2005 |
|
|
As Reported1 |
|
Adjustment |
|
Restatement |
Collaboration revenue |
|
$ |
|
|
|
$ |
146,977 |
|
|
$ |
146,977 |
|
Milestone revenue |
|
|
30,000,000 |
|
|
|
(30,000,000 |
) |
|
|
|
|
Research and development revenue |
|
|
14,671,508 |
|
|
|
24,287,938 |
|
|
|
38,959,446 |
|
Contract revenue |
|
|
2,237,115 |
|
|
|
(1,237,112 |
) |
|
|
1,000,003 |
|
Total revenues and other income |
|
|
47,006,960 |
|
|
|
(6,802,197 |
) |
|
|
40,204,763 |
|
Income (loss) from operations |
|
|
6,223,347 |
|
|
|
(6,802,197 |
) |
|
|
(578,850 |
) |
Income before income taxes |
|
|
7,213,116 |
|
|
|
(6,802,197 |
) |
|
|
410,919 |
|
Net income (loss) |
|
|
6,424,775 |
|
|
|
(6,802,197 |
) |
|
|
(377,422 |
) |
Basic net income (loss) per share |
|
|
1.68 |
|
|
|
(1.78 |
) |
|
|
(0.10 |
) |
Diluted net income (loss) per share |
|
|
1.63 |
|
|
|
(1.73 |
) |
|
|
(0.10 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive income (loss) |
|
|
6,457,463 |
|
|
|
(6,802,197 |
) |
|
|
(344,734 |
) |
U.S. Securities and Exchange Commission
March 29, 2007
Page 17
Impact on Consolidated Balance Sheet Items
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2005 |
|
|
As Reported1 |
|
Adjustment |
|
Restatement |
ASSETS:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred tax assets |
|
$ |
292,404 |
|
|
$ |
234,348 |
|
|
$ |
526,752 |
|
Total current assets |
|
|
47,092,459 |
|
|
|
234,348 |
|
|
|
47,326,807 |
|
Deferred tax assets noncurrent |
|
|
687,294 |
|
|
|
(234,348 |
) |
|
|
452,946 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS EQUITY (DEFICIT)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred revenue current |
|
$ |
16,599,457 |
|
|
$ |
12,496,260 |
|
|
$ |
29,095,717 |
|
Total current liabilities |
|
|
24,717,355 |
|
|
|
12,496,260 |
|
|
|
37,213,615 |
|
Deferred revenue, net of current portion |
|
|
25,333,589 |
|
|
|
(6,868,056 |
) |
|
|
18,465,533 |
|
Total liabilities |
|
|
52,596,744 |
|
|
|
5,628,204 |
|
|
|
58,224,948 |
|
Accumulated deficit |
|
|
(38,611,039 |
) |
|
|
(5,628,204 |
) |
|
|
(44,239,243 |
) |
Total stockholders (deficit) equity |
|
|
(3,683,832 |
) |
|
|
(5,628,204 |
) |
|
|
(9,312,036 |
) |
|
|
|
1 |
|
The As Reported amounts in the above tables were previously restated for
errors in the Companys deferred tax assets as of December 31, 2005 and fully vested
non-employee options granted during the year ended December 31, 2005. The restated
consolidated financial statements to correct these two errors were included in the amendment
to the Companys Registration Statement on Form S-1 filed with the Securities and Exchange
Commission on October 20, 2006. |
Revenue Recognition (Note 3)
Collaboration and License Agreements
The Companys primary sources of revenue include up-front payments, milestone payments,
reimbursements of development and co-promotion costs and royalties. The Company recognizes revenue
from these sources in accordance with Staff Accounting Bulletin (SAB) 104, Revenue Recognition
(SAB 104), Emerging Issues Task Force (EITF) No. 99-19, Reporting Revenue Gross as a Principal
Versus Net as an Agent, and EITF No. 00-21, Revenue Arrangements with Multiple Deliverables
(EITF 00-21). The application of EITF 00-21 requires subjective analysis and requires management
to make estimates and assumptions about whether deliverables within multiple-element arrangements
are separable from the other aspects of the contractual arrangement into separate units of
accounting and to determine the fair value to be allocated to each unit of accounting.
U.S. Securities and Exchange Commission
March 29, 2007
Page 18
The Company entered into a sixteen-year collaboration and license agreement (Takeda Agreement)
with Takeda in October 2004 and a supplemental agreement to the Takeda Agreement (Supplemental
Agreement) in February 2006 (see Note 11). The Company evaluated the multiple deliverables within
the Takeda Agreement and the Supplemental Agreement in accordance with the provisions of EITF 00-21
to determine whether the delivered elements that are the obligation of the Company, have value to
Takeda on a stand-alone basis and whether objective reliable evidence of fair value of the
undelivered items exists. Deliverables that do meet these criteria are evaluated separately for
the purposes of revenue recognition. Deliverables that do not meet these criteria are combined and
accounted for as a single unit of accounting.
The Companys deliverables under the Takeda Agreement and the Supplemental Agreement,
including the related rights and obligations, contractual cash flows and performance periods, are
more fully described in Note 11. The Takeda Agreement and the Supplemental Agreement consist of
the following key funding streams: up-front and milestone payments, reimbursements of development
and co-promotion costs and royalties. In accordance with EITF 00-21, the cash flows associated with
the individual units of accounting from the Agreement and the Supplemental Agreement are recognized
as revenue using a time-based model that recognizes the revenue ratably over the period in which
the Company completes its performance requirements. However, revenue is limited to amounts that
are nonrefundable and that Takeda is contractually obligated to pay to the Company. The Company
has determined that it is acting as a principal under the Agreement and, as such, records these
amounts as collaboration revenue and research and development revenue.
Royalties from licensees are based on third-party sales of licensed products and are recorded
on the accrual basis when earned in accordance with contractual terms when third-party results are
reliably measurable, collectability is reasonably assured and all other revenue recognition
criteria are met. Because of the lack of historical data regarding sales returns, royalty payments
related to the portion of sales by Takeda that are subject to a right of return are not reported as
revenue until the right of return lapses. For the year ended December 31, 2006, the Company
recognized approximately $6.6 million in royalty revenues.
Reimbursement of co-promotion costs under the Supplemental Agreement is recognized as revenue
as the related costs are incurred. The Company has determined that it is acting as a principal
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
$3.5 million of co-promotion revenue.
Option fees received for other potential joint collaboration and license agreements with
Takeda are not recognized as revenue immediately because the transactions do not represent a
U.S. Securities and Exchange Commission
March 29, 2007
Page 19
separate earnings process. Because there are contingent performance obligations by the Company
when and if the options are exercised, the Companys policy is to recognize revenue immediately
upon expiration of the option or to commence revenue recognition upon exercise of the option and
continue recognition over the estimated performance period. When recognized, option fees are
recorded as contract revenue.
Contract revenue related to development and consulting activities with related parties is
accounted for under the time based method and as performance is rendered, respectively. Cost
sharing payments received in advance are recorded as deferred revenue and recognized as revenue
over the applicable clinical trial period.
Other Revenue Sources
Revenues from the performance of research and development cost reimbursement activities under
a long-term strategic alliance agreement (see Note 10) are recorded over the period in which the
actual research and development activities have occurred, similar to the time-based model, which
was equivalent to the term of this agreement.
Contract revenue related to development and consulting activities with related parties is
accounted for over the period in which the services are completed, similar to the time-based model.
Cost sharing payments received in advance are initially recorded as deferred revenue.
Collaboration and License Agreements (Note 11)
On October 29, 2004, the Company entered into a 16-year collaboration and license agreement
with Takeda to exclusively co-develop, commercialize and sell products that contain lubiprostone
for gastroenterology indications in the United States and Canada. Payments to the Company under
the Takeda Agreement include a nonrefundable up-front payment, nonrefundable development and
commercial milestone payments, reimbursement of certain development and co-promotion costs and
royalties.
Upon execution of the Takeda Agreement, the Company was required to complete several
deliverables, which Takeda is responsible to fund. The following are the required deliverables of
the Company, along with the related contractual cash flows from Takeda and the associated
obligations and performance period of the Company, as of the execution of the Takeda Agreement:
|
|
The Company granted Takeda an exclusive license of lubiprostone to co-develop,
commercialize, and sell products for gastroenterology indications in the United States and |
U.S. Securities and Exchange Commission
March 29, 2007
Page 20
|
|
|
Canada. There are no defined contractual cash flows within the Takeda Agreement for the
grant of this license, but the Company did receive the nonrefundable up-front payment of $20
million upon executing the Takeda Agreement. The license was granted to Takeda on October
29, 2004 and will expire when the Takeda Agreement expires or is terminated earlier. Upon
commercial launch, Takeda shall, for the products sold by Takeda during the term of the
Takeda Agreement, pay Sucampo pre-determined royalties on net revenues on a quarterly basis.
The level of royalties is tiered based on the net sales recognized by Takeda. Royalty
payments, which Sucampo began to earn in April 2006 and receive in July 2006, will cease
when the Takeda Agreement is terminated and all cash payments due to Sucampo are paid. The
Company has recorded royalty revenues of approximately $6.6 million for the year ended
December 31, 2006. This revenue is recorded as royalty revenue in the consolidated
statements of operations and comprehensive (loss) income. |
|
|
|
|
The Company shall participate in the following committees, along with Takeda: Joint
Steering Committee, Joint Development Committee, Joint Commercialization Committee and
Joint Manufacturing Committee. There are no separate cash flows identified within the
Takeda Agreement associated with the participation by the Company in these committees.
There is no defined performance period for this obligation, but the performance period will
not exceed the term of the Takeda Agreement. The Company expects its participation on all
committees to continue throughout the term of the Takeda Agreement, except for the Joint
Development Committee, which will continue until development work is complete. |
|
|
|
|
The Company shall provide development work necessary for a New Drug Application (NDA)
for the treatment of chronic idiopathic constipation (Constipation) and irritable bowel
syndrome with constipation (C-IBS) indications. Takeda shall fund the initial $30 million
of development costs and the two parties shall equally share any required development costs
in excess of $50 million. Although there is no defined performance period for this
development work, the period to perform the work will not exceed the term of the Takeda
Agreement. In January 2006, the Company received approval for its NDA for AMITIZA to treat
Constipation and estimates that the NDA for C-IBS will be completed and submitted to the
FDA in June 2007. |
The Company has assessed these required deliverables to determine which deliverables are
considered separate units of accounting under the guidance of EITF 00-21. The Company was able to
specifically identify stand-alone value for the participation in the Joint Steering Committee, the
Joint Manufacturing Committee and the Joint Commercialization Committee by obtaining objective and
reliable evidence of the fair value of these deliverables,
including
U.S. Securities and Exchange Commission
March 29, 2007
Page 21
anticipated expenses expected to be incurred to meet its obligations, in the form of contract
agreements between the Company and specialized consultants for other development projects the
Company is and has been involved with currently and in the past. The Company was not, however,
able to distinguish the stand-alone value for participation in the Joint Development Committee from
its obligations to perform research and development of Constipation and C-IBS because the
participation in the Joint Development Committee was to occur concurrently with the development
work. Thus, the Company determined that there were four separate units of accounting when the
Takeda Agreement was executed (1) participation in the Joint Steering Committee, (2)
participation in the Joint Manufacturing Committee, (3) participation in the Joint
Commercialization Committee and (4) the combined requirement of the development work of
Constipation and C-IBS and participation in the Joint Development Committee.
The fair value associated with the three separately identified units of accounting related to
participation of committee meetings were based on obtaining objective and reliable evidence of the
fair value of these deliverables in the form of contract agreements between the Company and
specialized consultants for other development projects the Company is and has been involved with
currently and in the past. Upon receipt of the $20 million up-front payment, the Company deferred
approximately $2.4 to be recognized using the time-based model over the performance period of the
participation in these meetings. During the years ended December 31, 2004, 2005 and 2006, the
Company recognized approximately $24,000, $147,000, and $147,000, respectively, of this deferred
amount as collaboration revenue on the consolidated statements of operations and comprehensive
(loss) income. The related deferred revenue as of December 31, 2005 and 2006 was approximately
$2.2 million and $2.1 million, respectively.
Since the execution of the Takeda Agreement through December 31, 2006, the Company deferred
the residual amount of the $20 million up-front payment totaling approximately $17.6 million,
milestone payments received totaling $50 million, and reimbursement of the initial $30 million of
research and development costs for the development of AMITIZA for Constipation and C-IBS
indications. These deferred amounts were applied towards the unit of accounting combining the
participation in the Joint Development Committee and the development of Constipation and C-IBS and
are being recognized using the time-based model over the performance period of developing the
Constipation and C-IBS NDA submissions, which is estimated to be completed by June 2007. During
the years ended December 31, 2004, 2005 and 2006, the Company recognized approximately $2.8
million, $39.0 million and $46.4 million, respectively, of these deferred amounts as research and
development revenue on the consolidated statements of operations and comprehensive (loss) income.
The related deferred revenue as of December 31, 2005 and 2006 was approximately $35.8 million and
$11.0 million, respectively
U.S. Securities and Exchange Commission
March 29, 2007
Page 22
The Company incurred research and development costs for this development work of approximately
$1.5 million, $25.9 million and $ 11.6 million for the years ended December 31, 2004, 2005 and
2006, respectively. The Company has an express contractual obligation to perform the development
work under the Takeda Agreement, including for periods after receipt of funding by Takeda. Funding
from Takeda is received, in advance, on a quarterly basis based on estimated costs to be incurred
by the Company.
On February 1, 2006, the Company entered into the Supplemental Agreement with Takeda, which
amends the responsibilities of both the Company and Takeda for the co-promotion of AMITIZA and
clarifies the responsibilities and funding arrangements for other marketing services to be
performed by both parties.
Upon execution of the Supplemental Agreement, the Company was required to complete several
deliverables in which Takeda is responsible to fund. The following are the required deliverables
of the Company, along with the related contractual cash flows from Takeda and the associated
obligations and performance period of the Company, when the Supplemental Agreement was executed:
|
|
|
The Company shall co-promote AMITIZA with Takeda by employing a sales force of
approximately 38 representatives to supplement Takedas sales activities. Takeda shall
reimburse the Company a specified amount per day per sales force representative, but such
reimbursements shall not exceed certain pre-defined amounts. The term of this
reimbursement arrangement ceases five years following the first date that the Company
deployed sales representatives, which was in April 2006. The Company has recognized
approximately $3.5 million of revenues for the year ended December 31, 2006 reflecting
these co-promotion reimbursements, which is recorded as co-promotion revenue in the
consolidated statements of operations and comprehensive (loss) income. |
|
|
|
|
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 exceed the term of the Supplemental Agreement. The Company began
performing these activities in January 2006. The Company has recorded approximately
$779,000 of reimbursements of marketing costs for the year ended December 31, 2006. This
amount is recorded as a reduction to selling and marketing expenses in the consolidated
statements of operations and comprehensive (loss) income. |
During the quarter ended June 30, 2006, the Joint Commercialization Committee granted approval
for the Company and Takeda to begin three new studies related to funding arrangements discussed in
both the Takeda Agreement and the Supplemental Agreement. The
U.S. Securities and Exchange Commission
March 29, 2007
Page 23
following are the three additional deliverables of the Company, along with the related contractual
cash flows from Takeda and the associated obligations and performance period of the Company, when
the three studies were agreed upon:
|
|
|
The Company shall perform studies in connection with changes to labeling for
Constipation or C-IBS. Takeda shall fund 70% of the labeling studies and Sucampo shall
fund the remaining 30%. There is no defined performance period, but the performance period
will not exceed the term of the Takeda Agreement. The Company initiated the first labeling
study for Constipation in August 2006, which is expected to be completed in January 2008. |
|
|
|
|
The Company shall perform all development work for the development of an additional
indication for opioid-induced bowel dysfunction (OBD). Takeda shall fund all development
work up to a maximum aggregate of $50 million and $20 million for each additional
indication and new formulation, respectively. If development costs exceed these amounts,
Takeda and the Company shall equally share such excess costs. There is no defined
performance period, but the performance period will not exceed the term of the Takeda
Agreement. The Company initiated work on the first additional indication for AMITIZA in
July 2006, which is estimated to be completed in June 2009 and is expected to exceed $50
million in development costs. |
|
|
|
|
The Company shall perform all development work necessary for Phase IV studies, for which
Takeda shall fund all development work. There is no defined performance period, but the
performance period will not exceed the term of the Supplemental Agreement. The Company
began work on a Phase IV study for Constipation in August 2006, which is estimated to be
completed in January 2008. |
The Company has assessed these required deliverables to determine which deliverables are
considered separate units of accounting under the guidance of EITF 00-21. As a result of the
Company and Takeda agreeing to perform and fund these studies simultaneously, the Company
determined that there is no objective and reliable evidence to determine standalone value for each
of the studies. Accordingly, the Company has combined these three new required deliverables as a
single unit of accounting. All cash payments from Takeda related to these three deliverables will
be deferred upon receipt and recognized over the entire period to complete the three studies using
the time-based model. The estimated completion date is June 2009. During the year ended December
31, 2006, the Company recognized approximately $1.0 million related to these three deliverables as
research and development revenue on the consolidated statements of operations and comprehensive
(loss) income.
U.S. Securities and Exchange Commission
March 29, 2007
Page 24
The Company received $5.0 million as an option payment in 2004 to continue negotiations for
additional territories held by SPE and SPL. This agreement provided for negotiation terms of 12
months for the SPL territory and until NDA approval of AMITIZA for the SPE territory. Of the $5.0
million payment received, if negotiations did not succeed, a total of $2.5 million would be
required to be returned to Takeda ($1.0 million for the SPL territory and $1.5 million for the SPE
territory). The remaining $2.5 million was retained by the Company. As to that portion of the
option agreement relating to SPL ($2.0 million), the Company recorded $1.0 million as current
deferred revenue and $1.0 million as other liabilities short term in 2004. As to the option
payment relating to SPE ($3.0 million), the Company recorded $1.5 million as long term deferred
revenue and $1.5 million as other liabilities long term in 2004. Upon receipt of the payments
from Takeda, the refundable portions were recorded as an other liability and the non-refundable
portions were recorded as deferred revenue. The option right expired for SPL during 2005 and $1.0
million was returned to Takeda and the Company immediately recognized the deferred $1.0 million as
contract revenue for the year ended December 31, 2005. The option right expired for SPE during the
first quarter of 2006 and $1.5 million was returned to Takeda and the Company immediately
recognized the deferred $1.5 million as contract revenue for the year ended December 31, 2006. See
Note 3 for a discussion of the revenue recognition policy for option payments received by the
Company.
* * * * *
Under SFAS 154, paragraph 2h, the Company has a correction of an error as of December 31, 2006
and will restate its 2004 and 2005 consolidated financial statements under paragraph 25 and
corresponding disclosures under paragraph 26.
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.
If you have any questions or comments on the above, please contact either me at (202) 663-6224
or Bryant Morris at (202) 663-6058.
Respectfully,
/s/ Brent B. Siler
Brent B. Siler
U.S. Securities and Exchange Commission
March 29, 2007
Page 25
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Ms. Sonia Barros |
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Ms. Christine Allen |
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Mr. Kevin Woody |
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Mr. Mark Barrysmith |
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Securities and Exchange Commission |
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Sachiko Kuno, Ph.D |
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Mr. Ron Kaiser |
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Ms. Mariam Morris |
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Jeffrey D. Karpf, Esq. |