corresp
Sucampo Pharmaceuticals, Inc.
Memo
|
|
|
|
|
|
|
To:
|
|
Mark Barrysmith |
|
|
|
|
|
|
|
From:
|
|
Mariam Morris, CAO; Ron Kaiser, CFO |
|
|
|
|
|
|
|
CC:
|
|
PwC |
|
|
|
|
|
|
|
Date: March 3, 2007
|
|
|
|
|
|
|
|
Re:
|
|
Response to Discussions of February 22, particularly as they relate
to Substantive Development Milestone revenue incentives |
Thank you for our telephonic conversation on Thursday, February 22, 2007. Your assistance was
informative and helpful. During the conversation, the Company was asked to:
|
1. |
|
Re-evaluate and further substantiate the conceptual framework of the substantive milestone
method giving consideration to the levels of performance requirements included in the model
and the relationship between the up-front payment, the milestone payments and the R&D
reimbursement payments. In addition, provide information how the 3 additional studies that
were initiated in Q3 of 2006 fit into the framework of EITF 00-21; |
|
|
2. |
|
Provide further evidence of the costs involved in the individual projects or combined
projects such that the asymmetry of costs vs. revenues could be explained using the EITF 91-6
approach; and |
|
|
3. |
|
Provide an alternative analysis using the time-based model of revenue recognition, based on
Sucampos facts and circumstances if the substantive milestone method is not considered
appropriate by the Staff or if the substantive milestone method is not acceptable to the Staff
when it results in the recognition of revenue upon an event unless that event is at the end of
a period of performance |
The Staff requested further analysis regarding the asymmetric relationship between costs and
revenues of the deliverables for the EITF 91-6 analysis previously provided. The Company has
determined that applying a revenue model analogous to EITF 91-6 based on the proportion of costs
incurred to estimated total costs is not appropriate because the Company would not be able to
reasonably estimate its costs for the different deliverables due to the following reasons:
|
1. |
|
There is significant volatility in the Companys costs and significant reliance on third
parties to complete the studies; |
|
|
2. |
|
The FDA could change indication design and/or requirements at any time prior to the
filing of an sNDA or NDA application which could significantly impact costs and the
estimated study time; |
1
|
3. |
|
The Company is dependent upon the success of investigators to screen, enroll, and monitor
patients during the project; |
|
|
4. |
|
The Company is dependent upon contract research organizations (CROs) to execute a
significant amount of services for execution of our protocol. Due to various factors, the
Company may incur significant costs savings or cost overruns during the course of these
studies; |
|
|
5. |
|
Unpredictable patient responses during the course of the study, if adverse, could change
our protocol requirements which would thereby significantly change the study costs. |
As such, this memo does not address the asymmetric question and instead relies on the time period
involved to ratably recognize revenue.
This memo is designed to explain our qualitative and specific responses to the above mentioned
questions. It explains our position that the use of the substantive milestone method remains
appropriate based on the Companys facts and circumstances and addresses an alternative revenue
recognition model in accordance with GAAP to account for the Takeda Agreement transactions if the
Companys position regarding the substantive milestone method is not accepted.
As discussed with the staff, commercial milestones and royalties, while at risk for the Company,
have been excluded from this analysis due to their inherent unpredictability and direct correlation
to the sales efforts required by our partner. These commercial activities occur after the Companys
obligation to perform research and development activities under FDA guidelines ceases. Requests for
activities by the market and or regulatory agencies are the responsibility of the Companys
commercial partner and any further activities of the Company are determined and agreed to at the
time when the response to the request is made.
Specific arguments for the Substantive milestone method within the evaluation of this
agreement. The Company has historically recognized revenue research and development payments
related to the Takeda agreement in accordance with Staff Accounting Bulletin (SAB) No. 104,
Revenue Recognition (SAB 104) and Financial Accounting Standards Board (FASB) Emerging Issue
Task Force Issue No. 00-21, Accounting for Revenue Arrangements with Multiple Deliverables (EITF
00-21). Revenue-generating research and development collaborations are often found in multiple
element arrangements which provide for a license as well as research and development services.
Collaborations may involve substantive milestone payments, as this contract does. Substantive
milestone payments are considered to be performance bonuses that are recognized upon achievement of
a milestone and a completion of a separate earnings process. Milestones are used within Sucampos
industry as incentive(s) for innovators. They are a tool for large commercialization companies,
such as our partner, to hedge their financial risk of loss if certain significant development
events such as successfully completing a phase or achieving regulatory approval are not achieved.
The innovator or performing company such as Sucampo bears the risk of significant effort,
development, cost volatility, and outside technological advances by competitors until such time
that a milestone is achieved.
Such arrangements are analyzed under EITF 00-21 to determine whether the deliverables, including
research and development services, can be accounted for separately or as a single
Page 2
unit. The Company re-assessed the deliverables discussed in the Takeda Agreement using the
criteria of EITF 00-21 (specifically paragraph 9). The overall re-assessment of the deliverables
confirmed the Companys initial conclusion that the separate criteria under EITF 00-21 were not
met. As such, the Companys historic accounting for the payments related to the execution of the
Agreement (up-front payment) and development of indications for chronic idiopathic constipation
(CIC) and irritable bowel syndrome with constipation (IBS-C) (milestone payments and
reimbursements of R&D expenses) as a single-unit of accounting was deemed appropriate. The Company
adopted the substantive milestone method to account for this single unit of accounting.
In applying the five criteria under the milestone criteria, the Company determined which payments
received from Takeda were substantive and which were non-substantive. For those that were deemed
to be substantive, upon achievement of the milestone the payment would be recognized as revenue
immediately, if non-refundable. If the payment was deemed to be non-substantive and non-refundable,
the payment would be deferred upon receipt and recognized ratably over the relevant service time
period.
The Company determined that the up-front payment and reimbursements of R&D costs were not
substantive because they did not meet all five criteria of the substantive milestone method. As a
result, the Company amortized the payments ratably over the relative service periods (overall
agreement period for the up-front payment and the development period to file the NDA for CIC and
IBS-C for the reimbursement of R&D costs).
The following is a detailed analysis performed by management to illustrate managements detailed
assessment of which milestone payments were deemed substantive and which were deemed
non-substantive.
|
1. |
|
Achievement of the milestone involves a degree of risk which was not reasonably assured
at the inception of the arrangement. The performing company cannot be able to solely
control the milestone to be met without bearing risk and responsibility for substantial
efforts to be provided in the future. |
|
|
|
|
Managements assessment: Significant risk is involved in each individual development event
(such as assessing data in order to file a complete New Drug Application (NDA) or design a
Phase III clinical trial) and the development event is either defined by or determined in
negotiation with our commercialization partner. Failure to successfully reach the individual
development milestone event is relevant to us as we bear the risk that the development is not
successful and the risk that we might not reach the market in a viable time period to enable us
to successfully compete with current and upcoming drugs/drug candidates. |
|
|
|
|
Milestones that are achieved by the Company to upon regulatory approval by the FDA, while
appropriately giving consideration for a reasonable time period, are always considered
substantive. We believe that the risk of efforts is high to the Company because lack of approval
places the current drug at risk and the future development for our entire pipeline remains at
risk. In addition, during the substantive effort period associated with the study prior to
filing, the FDA may change the filing requirements or change the filing process from an
expedited process to a more lengthy process, which may put the entire project at risk. In
fact, on September 29, 2006, |
Page 3
the New York Times reported that only 1 in 14 drugs submitted to the FDA were approved on the
first try for 2006; that approval was made to the Company for the drug considered under the CIC
development phase of this agreement.
|
2. |
|
Substantive effort is involved in achieving the milestone |
|
|
|
|
Managements assessment: For each milestone payment Sucampo has received, a substantive amount
of development effort has been exerted by the Company, whether through internal labor hours or
by using third parties. Prior information received by the Staff showed the combined costs of
efforts for several of the milestones. Management reviews of the individual costs of efforts
related to the milestones for enrollment of the IBS-C patients, the filing of the CIC NDA and
the filing of the IBS-C sNDA had costs associated with them ranging from $2.9 million to $42
million and involved significant labor hours (3433, 6566, and 8529 (through 12/31/2006)
respectively. All substantive efforts associated with the approval milestones for the products
were expended prior to the filing of the application, but revenue recognition for these
milestones were required to be deferred until the amount became billable. |
|
|
3. |
|
Milestone payments are reasonable in relation to the effort expended or the risk
associated with achievement of the milestone |
|
|
|
|
Managements assessment: As discussed in #2 above, significant external costs and time have
been spent by the Company, including from key personnel, was spent on each milestone event. The
individual milestone payments are noted in the table following this five point analysis. Because
the efforts involved in the IBS-C studies were substantially greater in terms of the efforts
involved to conduct the CIC studies and because of the size of the studies themselves ( the CIC
efficacy study size was 479 subjects and the IBS-C efficacy study size was 1171 subjects), the
comparative revenues associated with the IBS-C study were deemed by the Company to be
appropriate. It should also be noted that extensive discussions and negotiations with the
Companys commercialization partner were conducted in order for the two independent parties to
agree upon the relative value of each milestone as any one of them could be cancelled and each
party would have been the recipient only of prior payments and benefits at the time of
cancellation. |
|
|
4. |
|
A reasonable amount of time passes between the upfront license payment and the first
milestone payment as well as between each subsequent milestone payment |
|
|
|
|
Managements assessment: Each milestone included a reasonable amount of time between the
up-front payment and the individual milestones. The shortest time period (6 months) was between
the up-front payment and the initial $10 million milestone payment for the filing of an NDA for
CIC by the Company. The Company considers this 6-month time period reasonable for receiving a
$10 million payment in comparison to the longer time intervals for the other milestone payments
that were in excess of $10 million, particularly as it had not previously filed an NDA with the
FDA and to do so required considerable effort between the up-front payment and the achievement
of this milestone. The second $20 million milestone event was received 2 months later, but this
was for another drug indication (IBS-C) that required a |
Page 4
|
|
separate level of effort. Because the Company was conducting simultaneous development activity
for two different indications (as required under FDA guidelines), the Company did not deem
combining these two milestones for this specific assessment was appropriate. |
|
5. |
|
A comparison between the values and risks of the milestone payments and the up-front
payment |
|
|
|
Managements assessment: Based on an overall comparison between the individual milestones and
the up-front payment, the Company believes that the comparison is reasonable. The milestones
generally increase in value as the development work is more extensive or the risk is higher.
For example, the Company received a $10 million milestone for filing the CIC NDA, but a $20
million for obtaining approval for the CIC NDA and $20 million for initiating a Phase III trial
for IBS-C. In comparison to the $10 million milestone, the approval of the CIC NDA milestone
has higher risk, as noted above, and the IBS-C phase III trials initiation would be more
extensive in terms of the number of patients, the amount of study efforts, and the completion of
acceptable study protocols required to achieve a filing status. |
Based on the analysis of the 5 criteria listed above, the Company assessed each of the following
individual milestones and determined the substantive nature of each milestone to be:
|
|
|
|
|
|
|
Milestone |
|
Amount |
|
Date Achieved |
|
Substantive (Y/N) |
CIC Filing of NDA |
|
$10,000,000 |
|
March 31, 2005 |
|
Y |
|
|
|
|
|
|
|
IBS-C First
Patient Enrolled |
|
$20,000,000 |
|
May 13, 2005 |
|
Y |
|
|
|
|
|
|
|
CIC
NDA Approval |
|
$20,000,000 |
|
January 1, 2006 |
|
Y |
|
|
|
|
|
|
|
IBS-C Filing of NDA |
|
$30,000,000 |
|
May 2007 (estimate) |
|
Y |
We continue to believe that each of our milestones is substantive due to the analysis
discussed above. We acknowledge that the Staffs question regarding this conceptual framework
would be hindered by on-going performance of substantial efforts after each such milestone is
achieved. In an effort to address the Staffs comment, the Company has evaluated this concern and
has determined that all costs to reach each substantive milestone were incurred prior to its
completion.
Additional Indications/Formulation/Regulatory Required Studies: At the initiation of the
underlying agreement, Sucampo and its partner determined that there were a set of activities that
were associated with the establishment of Sucampos Amitiza® product for the indications of CIC and
IBS-C. If these efforts were successfully completed and resulted in successful regulatory filings
and/or approvals, and if market conditions warranted (such conditions included unsuccessful studies
effected by other companies for similar product programs) Sucampo and its partner would embark upon
Page 5
additional deliverable projects as determined by section 4.2 (iv) of the contract and entitled
Additional indications in the US on a cost sharing basis.
The second project for Additional indications in the US became established in July of 2006. Upon
execution of the Companys collaboration agreement on October 29, 2004, the Company had completed a
Phase I efficacy study for opioid induced bowel Dysfunction (OBD). While, this small study was
positive, both companies had determined that entrance of our compound into the OBD market would NOT
be commercially viable when compared against the level of economic investment required to bring the
compound through the development cycle (Phase II and Phase III would still need to be completed and
a supplemental New Drug Application (sNDA) would be required) . In addition, because regulatory
approval for Amitiza had not been established, both parties agreed that both the development risk
and commercial return was not viable for either party at that time.
More specifically at the initiation of the agreement the two parties agreed that by the time the
parties could successfully develop the drug, the market would be too saturated to satisfy any
return to our partner. At the time, Adalor was the leading entrant to the market as their OBD
candidate, Entereg, was in Phase III. In the second quarter of 2006, we became aware through our
monitoring of filing information that our competitor, Adalor, might not obtain approval from the
FDA. At this juncture we agreed with our partner that, should we successfully develop both Phase
II and III for OBD, the entrance into the market before any additional competitors could return
more than the current development expenses. Unlike CIC or IBS-C, which can be prescribed primarily
by general practitioners in response to patients overall symptoms and/or number of bowel movements,
OBD is a disease specifically induced by other drugs. The target market for OBD, if successful,
will depend upon how well our partner is at targeting patients in its eligible markets who are on
long term opioid therapies such as oncology (cancer) patients. Under FDA guidelines, successful
application will require an sNDA regardless of the fact that the primary drug had been previously
approved. At the time that this new study was agreed upon and designed with our partner, Sucampo
was willing to make an investment in OBD of an estimated $1.7 million, in comparison to its
partners estimated investment of $51.7 in order to reach an NDA filing status. Our partner was
willing to commit to pay the first $50 million of the study and to pay 50% of the remaining
estimated costs to complete the study because it could add this new indication to its existing
sales force and expand the market into a segment in which there would be little or no competition.
During 2006, the Company had significant success which allowed the partners to re-assess the
development pipeline for our drug. On January 31, 2006, the Company received FDA approval for
Amitiza. However, at such time, the parties were required by the FDA to commit to conduct a
pediatrics trial for Amitiza (Phase IV). It is important to note about this trial that Phase IV
trials are clinical trials which are undertaken for approved drugs as part of the commercialization
process. Under the terms and conditions of the Contract (per Section 4.2 (iv)), we were under no
obligation to perform this trial as this trial could have been conducted by our partner and because
the parties could elect not to perform the trial at all. Subsequent to our approval, we were asked
to perform this study by our partner due to our accumulated proprietary knowledge to design an
effective protocol and execute such protocol in a timely manner to meet the commercialization needs
of our partner. This deliverable could not be anticipated upon initiation of the contract as its
request only occurred upon NDA approval, the Companys involvement was entirely discretionary and
only established in negotiation with its partner at the time of the request, and the Company would
have only entered into agreement to perform the study based on its independent assessment of the
economic benefits at the
Page 6
time. As such, the Company would account for this deliverable separately from the CIC/ IBS-C
deliverables.
Upon approval, the FDA also required the two companies to commit to conduct two small studies for
Renal/Hepatic Impairment (drug safety on the liver and kidney) as Phase IV studies. Under the
terms and conditions of the contract, this was Takedas obligation under section 4.2 (vi). However,
because the protocol of the study is more specific to the drugs safety and because both Takeda and
Sucampo would receive benefit from the study results, both parties agreed that the study should be
performed. The Staff has asked why the Company would perform the Renal and Hepatic studies and
lose money. To answer, one must also understand the amount of proprietary knowledge that the
Company has retained under this contract (which is often times transferred or shared in
collaboration agreements). Additionally, the Company would benefit economically if the research
contributed to successful commercialization as it might receive increased royalties in the US and
be able to assert a competitive advantage in the US and other markets. Under the terms and
conditions of the contract, the Company holds all proprietary knowledge as well as the risk to
maintain NDA. Because the Company has not agreed to share the knowledge of its core technology, it
agreed to participate in these studies. This decision was strategically determined given that our
remaining pipeline, which we plan to develop ourselves, is built upon this same core technology.
Securing our intellectual property is imperative to the on-going development of our pipeline in
order to be competitive. While we can not say that there is any immediate economic return to
take on this development on a shared cost basis, to do otherwise would have put at risk our
remaining pipeline and the future profitability we could gain with future collaboration partners.
Conclusion regarding the Substantive Milestone method. The Company again asserts that it
believes that the substantive milestone method is appropriate and its historic financial statements
included in its Form S-1 are presented free of material misstatements. We believe that the
substantive milestone method has not misled the users of our financial statements in understanding
the risks born by us developmentally or economically under this collaboration agreement.
Alternative Approach in Using a Time-Based Model for Revenue Recognition
The Staff has requested that Sucampo provide an alternative time-based model to recognize
revenue for this agreement. The Company believes that the following analysis is appropriate if the
substantive milestone method is not considered appropriate by the Staff.
As previously noted, the volatility in our costs does not allow the Company to effectively utilize
EITF 91-6 as a method of recognizing revenue for our research and development deliverables. As
such, the Company has included a time based model in response to the Staffs request which allows
the Company to recognize its revenues over the development period of the respective studies. In
this model the Companys assumptions give effect to the life cycle of drug development under the
protocol established by the FDA while ensuring that EITF 00-21 paragraph 8 is assessed. Research
and development activities include: protocol design, acceptance by the FDA of the protocol,
engagement of CROs, investigator recruiting, patient enrollment, patient observations over the
drug delivery and assessment period, and delivery of the final report to the FDA at the time of the
filing of the NDA or sNDA. Specifically, our analysis resulted in concluding that there were two
projects
Page 7
identified as separate deliverables under the agreement. These were 1, the development of the CIC
and IBS-C research and development activities that were required at the initiation of the agreement
and 2, the OBD research and development activities project that was agreed upon in July of 2006 as
noted in the discussion above. In developing our time-based model, these projects were accounted
for under the following assumptions:
|
1. |
|
For reasons cited, CIC/IBS is treated separately from OBD. |
|
|
2. |
|
For CIC/IBS, all cost reimbursements and milestones are recognized ratably, upon
receipt, through the estimated completion date of development obligations. As cost
reimbursements and milestones become due to the Company, a cumulative adjustment is also
recorded based upon time elapsed since the inception of the agreement (October 29, 2004)
relative to the total expected period through completion of development. Completion of
development is currently estimated to be May 31, 2007. We did give effect for any changes
in estimates that would have occurred between the inception of the agreement and the
current estimated time to complete. |
|
|
3. |
|
For OBD, all cost reimbursement and milestones are recognized ratably, upon receipt,
through the estimated completion date of all development obligations. As cost
reimbursements and milestones become due to the Company, a cumulative adjustment is also
recorded based upon time elapsed since the inception of the agreement to undertake OBD
studies (July 2006) relative to the total expected period through completion of
development. Completion of OBD development is estimated to be June 30, 2009. |
|
|
4. |
|
Revenue for Phase IV studies, are separate deliverables and are recognized ratably
over their respective development periods established and requested by our
commercialization partner when the two parties agree on the deliverables (NOTE: As the
commercialization partner, Takeda is primarily responsible for all Phase IV and labeling
efforts and Sucampo only is required to participate at the time it agrees with Takeda to
actually undertake the study, at which time Sucampo may participate in cost sharing as it
assesses its economic benefits from the efforts. At that time, the parties agree on the
reimbursement of expenses). |
|
|
5. |
|
We have followed two alternate approaches for the upfront fee. The first approach is
to recognize the fee ratably from the inception of the agreement through the term of the
agreement (December 31, 2020). The second approach is to recognize the fee ratably from
the inception of the agreement through the estimated completion date of all development
obligations anticipated under the agreement, currently estimated to be June 30, 2009 upon
final delivery of OBD. |
Conclusion regarding the alternative time-based model approach . If the substantive
milestone method is no longer deemed acceptable by the Staff in consideration of these facts and
circumstance, the Company believes it would be acceptable to convert to a time based revenue
recognition model whereby the $20 million upfront payment continues to be deferred and amortized
over the performance period of the research and development activities obligated by the agreement
and the milestones and research and development reimbursements are recognized ratably over the
service
period of the indications to which the respective research and development efforts are expected.
See appendix B for a comparison of the Companys existing revenue presentation with a presentation
of
Page 8
revenue under a time based approach revenue recognition model. Please note that this time based
approach is preliminary as it has not been subjected to management review or external audit.
Finally, while we recognize that the SEC has noted that it will not rely on industry practice
as a basis for a Companys accounting position, we believe that the following qualitative argument
for the substantive milestone method is worth noting:
Based on a review of other public registrants SEC filings, we have noted that the substantive
milestone method has been utilized by numerous public registrants, particularly after SAB 101 was
adopted. A majority of the disclosures within the financial statements included in the Forms 10-K
and 10-Q include discussion regarding the use of the substantive milestone method for agreements
that include up-front payments, milestone payments, and reimbursements of R&D expenses similar to
the Companys agreement. Our conversation with you has led us to further evaluate our support for
this position (which was discussed in the memo above) but we continue to assert that our use of the
substantive milestone method is consistent with these other public filings. Without using this
method, we believe that it would cause us to be differently perceived by the market when compared
by a reasonable investor to other companies in our industry. Accompanying this memo (appendix A) is
a list of comparable companies which have accounted for their revenue using a similar manner as
Sucampo. It is specifically noted that some of these identified companies were allowed to change
their accounting from the application of EITF 91-6 to the substantive milestone method under SAB
101 in 2001.
The substantive milestone method has been an acceptable model easily understood by the users of our
financial statements. The substantive milestone method easily communicates the economic
arrangements within the underlying collaboration agreement to our investors and the risks born by
the Company. Our disclosures are fully transparent and in many ways requires fewer judgments and
estimates than the alternative methods discussed. We believe a change could result in making it
difficult for users of our financial statements to make appropriate and informative comparisons
between us and other similar companies.
Accordingly, the Company believes that the substantive milestone method is appropriate and its
historic financial statements included in its Form S-1 are presented free of material
misstatements. We believe that the substantive milestone method has not misled the users of our
financial statements in understanding the risks born by us developmentally or economically under
this collaboration agreement.
Page 9
Sucampo Pharmaceuticals
Comparable Companies Substantive Milestone Method
Appendix A
|
|
|
Company Name |
|
|
Achillion Pharmaceuticals Inc
|
|
|
Adalor Corporation |
|
|
Advancis Pharmaceutical Corporation
|
|
|
Affymax |
|
|
Amylin |
|
|
Avanir |
|
|
Coley Pharmaceutical Group |
|
|
Curis Inc |
|
|
CV Therapeutics |
|
|
Decode Genetics Inc |
|
|
DOV Pharmaceutical, Inc. |
|
|
Elite Pharmaceuticals Inc |
|
|
Emergent Biosolutions |
|
|
Genentech, Inc. |
|
|
Incara Pharmaceuticals, Inc. |
|
|
Medimmune, Inc. |
|
|
Osiris Therapeutics |
|
|
Pozen |
|
|
Progenics Pharmaceuticals Inc |
|
|
Regeneron Pharmaceuticals Inc |
|
|
Renovis |
|
|
Replidyne |
|
|
Targacept |
|
|
Telik |
|
|
Trubion Parmaceuticals |
|
|
Vertex Pharmaceuticals Inc |
|
|
Sucampo Pharmaceuticals
Revenue TIME Based Model
AS OF DECEMBER 31, 2006
Appendix B
PRELIMINARY SUBJECT TO AUDIT AND MANAGEMENT REVIEW
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TIME BASED MODEL |
|
TIME BASED MODEL |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ratably over the time In |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
which substantive effort is |
|
Ratably over the time In which |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
required - Upfront is |
|
substantive effort is required |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
amortized ovar life of |
|
Upfront is amortized over R&D |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
contract |
|
period |
|
|
Currently Presented in Financial Statements |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Difference - |
|
|
|
|
|
Difference - |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
overstated / |
|
|
|
|
|
overstated / |
|
|
Up-front |
|
Milestones |
|
R&D Reimb. |
|
Total |
|
Revenue |
|
(understated) |
|
Revenue |
|
(understated) |
|
|
|
|
|
|
|
Q4-2004 |
|
|
206,186 |
|
|
|
|
|
|
|
1,482,337 |
|
|
|
1,688,523 |
|
|
|
1,688,523 |
|
|
|
|
|
|
|
3,020,799 |
|
|
|
(1,332,276 |
) |
|
|
|
|
|
|
|
|
2004 YTD |
|
|
206,186 |
|
|
|
|
|
|
|
1,482,337 |
|
|
|
1,688,523 |
|
|
|
1,688,523 |
|
|
|
|
|
|
|
3,020,799 |
|
|
|
(1,332,276 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Q1-2005 |
|
|
309,278 |
|
|
|
10,000,000 |
|
|
|
4,286,898 |
|
|
|
14,596,174 |
|
|
|
5,693,893 |
|
|
|
8,902,281 |
|
|
|
7,692,308 |
|
|
|
6,903,866 |
|
Q2-2005 |
|
|
309,278 |
|
|
|
20,000,000 |
|
|
|
3,461,536 |
|
|
|
23,770,814 |
|
|
|
11,078,509 |
|
|
|
12,692,305 |
|
|
|
13,076,923 |
|
|
|
10,693,891 |
|
Q3-2005 |
|
|
309,278 |
|
|
|
|
|
|
|
3,461,538 |
|
|
|
3,770,816 |
|
|
|
7,232,355 |
|
|
|
(3,461,539 |
) |
|
|
9,230,769 |
|
|
|
(5,459,853 |
) |
Q4-2005 |
|
|
309,276 |
|
|
|
|
|
|
|
3,461,538 |
|
|
|
3,770,816 |
|
|
|
7,232,355 |
|
|
|
(3,461,539 |
) |
|
|
9,230,769 |
|
|
|
(5,459,953 |
) |
|
|
|
|
|
|
|
|
|
2005 YTD |
|
|
1,237,112 |
|
|
|
30,000,000 |
|
|
|
14,671,508 |
|
|
|
45,908,620 |
|
|
|
31,237,112 |
|
|
|
14,671,508 |
|
|
|
39,230,769 |
|
|
|
6,677,851 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Q1-2006 |
|
|
309,276 |
|
|
|
20,000,000 |
|
|
|
3,868,885 |
|
|
|
24,178,163 |
|
|
|
20.309,278 |
|
|
|
3,868,885 |
|
|
|
22,307,692 |
|
|
|
1,870,471 |
|
Q2-2006 |
|
|
309,278 |
|
|
|
|
|
|
|
2,980,769 |
|
|
|
3,290,047 |
|
|
|
8,031,171 |
|
|
|
(4,741,124 |
) |
|
|
10,029,586 |
|
|
|
(6,739,539 |
) |
Q3-2006 |
|
|
309,278 |
|
|
|
|
|
|
|
2,207,587 |
|
|
|
2,516,865 |
|
|
|
6,169,208 |
|
|
|
(3,652,343 |
) |
|
|
6,244,545 |
|
|
|
(3,727,680 |
) |
Q4-2006 |
|
|
309,278 |
|
|
|
|
|
|
|
3,694,759 |
|
|
|
4,004,037 |
|
|
|
6,809,672 |
|
|
|
(2,805,635 |
) |
|
|
6,885,009 |
|
|
|
(2,880,972 |
) |
|
|
|
|
|
|
|
|
|
2006 YTD |
|
|
1,237,112 |
|
|
|
20,000,000 |
|
|
|
12,752,000 |
|
|
|
33,989,112 |
|
|
|
41,319,328 |
|
|
|
(7,330,216 |
) |
|
|
45,466,832 |
|
|
|
(11,477,720 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
2,680,410 |
|
|
|
50,000,000 |
|
|
|
28,905,845 |
|
|
|
81,586,255 |
|
|
|
74,244,963 |
|
|
|
7,341,292 |
|
|
|
87,718,400 |
|
|
|
(6,132,145 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2007Estimated: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Q1 - 2007 |
|
|
309,278 |
|
|
|
0 |
|
|
|
6,344,761 |
|
|
|
6,654,039 |
|
|
|
22,601,964 |
|
|
|
(15,947,925 |
) |
|
|
22,677,302 |
|
|
|
(16,023.263 |
) |
Q2 - 2007 |
|
|
309,278 |
|
|
|
30,000,000 |
|
|
|
9,570,627 |
|
|
|
39,879,905 |
|
|
|
39,660,488 |
|
|
|
219,417 |
|
|
|
39,735,825 |
|
|
|
144,080 |
|
Q3 - 2007 |
|
|
309,278 |
|
|
|
|
|
|
|
10,118,416 |
|
|
|
10,427,694 |
|
|
|
5,879,439 |
|
|
|
4,548,255 |
|
|
|
5,954,776 |
|
|
|
4,472,918 |
|
Q4 - 2007 |
|
|
309,278 |
|
|
|
|
|
|
|
9,764,298 |
|
|
|
10,073,576 |
|
|
|
5,611,329 |
|
|
|
4,462,247 |
|
|
|
5,686,666 |
|
|
|
4,386,910 |
|
|
|
|
|
|
|
|
|
|
2007 EYTD |
|
|
1,237,112 |
|
|
|
30,000,000 |
|
|
|
35,798,102 |
|
|
|
67,035,214 |
|
|
|
73,753,220 |
|
|
|
(6,718,006 |
) |
|
|
74,054,570 |
|
|
|
(7,019,356 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2008 EYTD |
|
|
1,237,112 |
|
|
|
50,000,000 |
|
|
|
23,353,949 |
|
|
|
74,591,061 |
|
|
|
68,823,435 |
|
|
|
5,767,626 |
|
|
|
69,124,785 |
|
|
|
5,466,276 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2009 EYTD |
|
|
1,237,112 |
|
|
|
|
|
|
|
2,237,620 |
|
|
|
3,474,732 |
|
|
|
9,865,643 |
|
|
|
(6,390,911 |
) |
|
|
9,397,762 |
|
|
|
(5,923,030 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2010 EYTD |
|
|
1,237,112 |
|
|
|
10,000,000 |
|
|
|
|
|
|
|
11,237,112 |
|
|
|
11,237,112 |
|
|
|
|
|
|
|
10,000,000 |
|
|
|
1,237,112 |
|
|
|
|
|
|
|
|
|
|
Total |
|
|
7,623,858 |
|
|
|
140,000,000 |
|
|
|
90,295,516 |
|
|
|
237,924,374 |
|
|
|
237,924,374 |
|
|
|
|
|
|
|
250,295,516 |
|
|
|
(12,371,142 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Estimated Remaining Under Contract |
|
|
|
|
|
|
|
|
|
|
12,371,142 |
|
|
|
12,371,142 |
|
|
|
|
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Contract |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
250,295,516 |
|
|
|
250,295,516 |
|
|
|
|
|
|
|
250,295,516 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Assumptions
Milestones are recognized ratably over the developmental period to which there is a contractual
obligation for performance, changes in estimates made for changes in project lime period
Upfront is recognized ratably over the life of the contract or final research and development
obligation
Research & Development is recognized ratably over the development period to which there is a
contractual obligation to perform.
Milestones for IBS approval and OBD approval are recognized immediately, however if there is any
associated performance obligation with them, which may
be mandated by FDA (unknown), will be released ratably over remaining performance period.
*revenue is recognized to extent that revenue has been received