corresp
Via EDGAR (Correspondence)
May 29, 2008
Mr. Jim B. Rosenberg
Senior Assistant Chief Accountant
Division of Corporation Finance
Securities and Exchange Commission
100 F Street N.E.
Washington, D.C. 20549
Re: Biogen Idec Inc.
Form 10-K for the Fiscal Year Ended December 31, 2007
Filed February 14, 2008
File No. 000-19311
Dear Mr. Rosenberg:
This letter sets forth the response of Biogen Idec Inc., a Delaware corporation (the Company,
we or us), to the comments of the Staff of the Division of Corporation Finance of the
Securities and Exchange Commission (the Staff) as set forth in our conversation with the Staff on
May 15, 2008 regarding the above-referenced annual report on Form 10-K.
For reference purposes, the text of the Staffs oral comments has been provided herein in bold. Our
responses follow each of the comments.
Please refer to your response to Comment 5 in your letter dated April 2, 2008.
Please expand your disclosures of these research agreements to address the following, include any
other information about the agreement you deem significant.
|
|
|
Discuss the purpose of the agreements, the significant terms and characteristics of the
agreements including the assets contributed by each party, the services to be delivered by
each party, the contract period, and the rights and obligations of each party. |
|
|
|
|
Disclose your accounting in more detail, as appropriate. For example, disclose the
basis for your conclusion that you are the primary beneficiary of the variable interest
entities (VIEs). Discuss how you determined your variable interests in the entities. |
As noted in our previous letter, during 2007, we entered into research collaboration agreements
with Cardiokine Biopharma, LLC and Neurimmune SubOne, in which we obtained developmental and
commercialization rights to their biological compounds. Cardiokine Biopharma, LLC and Neurimmune
SubOne, which were created specifically and solely to develop and commercialize these biological
compounds, are wholly-owned subsidiaries (the Subsidiaries) of their respective parent companies,
Cardiokine Inc. and Neurimmune Therapeutics, AG, (the Parents). The collaboration agreements
with Cardiokine Biopharma, LLC and Neurimmune SubOne are effective for 10 and 12 years,
respectively, from the date of the first commercial sale of a product using such compounds.
Biogen
Idec, 14 Cambridge Center Cambridge MA 02142 Phone 617 679 2000
www.biogenidec.com
1
Under each of the research collaboration agreements, the Parents contributed intellectual property
into the Subsidiaries. Specifically, these assets were biological molecules, research processes
and platforms, and any other knowledge related to developing the molecules into therapeutic agents
(intellectual property or IP). In exchange for the transfer of the intellectual property, the
Parents received 100% of the equity in the Subsidiaries. The Subsidiaries are required to perform
research and development services pursuant to the research collaboration on the contributed IP, in
exchange for funding of approximately 100% by Biogen Idec. The Subsidiaries will also receive
milestone payments upon the successful completion of various developmental activities and royalty
payments resulting from any commercial product net sales from Biogen Idec. Through these research
collaboration agreements, Biogen Idec acquired all of the rights and obligations associated with
development of the molecules and commercialization of any product resulting from the development.
The Subsidiaries only have the right to reimbursement of research and development costs,
contractual milestone and royalty payments pursuant to the research collaboration with Biogen Idec.
We have an established process of evaluating whether our research collaborations are within the
scope of FIN 46(R). If so, we assess whether the counterparty is a variable interest entity (VIE).
If the counterparty is a VIE, then we assess whether we have an interest in a specified asset of
the VIE or an interest in the entire VIE. If we have an interest in the entire VIE, then we assess
whether our collaboration agreement absorbs a majority of the expected losses or receives a
majority of residual returns of the VIE to determine if we are the primary beneficiary of the VIE.
We concluded that the Subsidiaries were VIEs because their equity investment at risk was
insufficient to finance their activities without financial support from outside parties (paragraph
5a of FIN 46(R)). The initial capitalization of these Subsidiaries was nominal relative to the
expected costs of developing the IP into commercial products. Furthermore, we participated in the
creation of the Subsidiaries, which resulted in us having the right to make all significant
decisions regarding the contributed IP, the only asset(s) in the Subsidiaries.
We believe that the research collaboration agreements are variable interests because these
contractual arrangements absorb the variability of the assets and liabilities (expected losses) of
the respective entities. Since the activities of these entities are limited to those associated
with research and development of the respective assets, their expected losses consist primarily of
research and development costs and any variability in those costs. The collaboration agreements
require us to absorb any variability in those costs. To further explain, assume that the estimated
cost of developing a molecule into a commercial product is $100 million. If the actual amount of
development is $150 million, the research collaboration requires Biogen Idec to absorb (pay) the
additional $50 million. Similarly, if the actual amount of the development is $80 million, Biogen
Idec receives the $20 million benefit through reduced payments to the Subsidiaries for development
costs.
Since the research collaborations require us to absorb a majority of the expected losses and
receive a majority of residual returns of the Subsidiaries, we concluded that we are the primary
beneficiary.
While we concluded that the Subsidiaries are VIEs and we are the primary beneficiary, we have
several other collaborations, as noted in Note 15, Research Collaborations, in our 2007 Form 10-K,
where our counterparty is not a VIE or if it is a VIE, we are not the primary beneficiary. Those
conclusions were based on the same established FIN 46(R) evaluation process described above.
2
Paragraph 23 of FIN 46(R) provides for the required disclosures of the primary beneficiary of a
VIE. Specifically, paragraph 23 requires disclosure of the (a) nature, purpose, size, and
activities of the variable interest entity, (b) carrying amount and classification of consolidated
assets that are collateral for the variable interest entitys obligations, and (c) lack of recourse
if creditors (or beneficial interest holders) of a consolidated variable interest entity have no
recourse to the general credit of the primary beneficiary. Only the requirements in paragraph 23a
are applicable to the Subsidiaries. The Subsidiaries have no assets (other than the IP asset(s),
which value was charged to IPR&D expense), liabilities or creditors.
We believe that our disclosures in our 2007 Form 10-K addressed the requirements of paragraph 23a
and provide readers of our financial statements sufficient information to understand the
transaction and underlying terms of the collaboration agreement. We also believe that the
disclosures include the items that you have suggested in your comments noted above and in your
previous letter. However, based on your comments, we intend to expand some of our disclosures to
better assist our readers in understanding these research collaborations. To further facilitate
your review, we have provided an analysis of our disclosure and our proposed additional language in
Exhibit A.
Please clarify why there is no minority interest on your balance sheet as a result of your
consolidation of the VIEs. It does not appear that you have any direct interests in Cardiokine
Biopharma, LLC or Neurimmune SubOne.
We do not have an ownership interest in either of the Subsidiaries. We consolidate these entities
under the variable interest model required under FIN 46(R).
We do not present a minority interest on our balance sheet, as the carrying value of the minority
interest is zero. The initial value of the minority interest on the balance sheet was $64 million
based on their 100% interest in the contributed IP but that amount was reduced to zero when we
recorded the benefit from minority interest holders 100% interest in the losses recorded by the
Subsidiaries. In substance, we allocated the value of the IPR&D charge ($64 million) entirely to
the minority interest holder due to their 100% equity interest. Additional information is provided
in the journal entries below.
Provide a consolidation journal entry to help us understand your accounting treatment for IPR&D and
the consolidation of your VIEs.
The consolidated impact of consolidating the Subsidiaries was as follows:
|
|
|
Cash decreased and R&D expense was recorded ($52 million); |
|
|
|
|
IPR&D expense and Minority Interest income were recorded ($64 million); and |
|
|
|
|
Minority Interest liability was recorded ($64 million), which represents the Parents
interest in the contributed IP. This amount was subsequently fully offset when the
minority interest income ($64 million) was recorded. |
The following entries were recorded to consolidate the Subsidiaries with Biogen Idec. All numbers
are in millions.
3
|
|
|
|
|
|
Dr: R&D Expense |
$52 |
|
|
|
Cr: Cash |
|
|
$52 |
To record the upfront payment to Subsidiaries to enter into the collaboration agreements. Through
the research collaborations, Biogen Idec received an R&D asset that did not have an alternative
future use. Consequently, the amount was recorded as R&D expense, as required by SFAS 2.
|
|
|
|
|
|
Dr: IPR&D Asset |
$64 |
|
|
|
Cr: Minority Interest Liability |
|
|
$64 |
To record the fair value of the minority interest liability as required by paragraph 18 of FIN
46(R). Through the research collaborations, the Parents retained a
portion of the Subsidiaries
assets, which is recorded as a minority interest liability in Biogen Idecs consolidated financial
statements.
|
|
|
|
|
|
Dr: IPR&D expense |
$64 |
|
Cr: IPR&D Assets |
|
|
$64 |
To write off IPR&D assets that has no alternative future use, as required by SFAS 2.
|
|
|
|
|
|
Dr: Minority Interest Liability |
$64 |
|
Cr: Minority Interest Income |
|
|
$64 |
To allocate loss of Subsidiaries, this reflects the IPR&D charge to the minority interest. Biogen
Idec does not have an ownership interest in the Subsidiaries.
Explain how you determined that $64 million related to the value retained by the minority interest.
The $64 million initial value of the minority interest reflects the value of the IP asset retained
by the equity holders, which was determined through a probability-adjusted discounted stream of
cash flows that the equity holders of the Subsidiaries may receive over the life of the research
collaboration agreements. The cash flows are driven by expected distributions to the equity
holders. The sole cash generating activity of the Subsidiaries relates to the collaboration
agreement with Biogen Idec. (Note: The Subsidiaries are contractually precluded from engaging in
any other activities.) The Subsidiaries have no other rights or obligations. The amounts of the
milestone payments and the royalty percentages are stipulated in the collaboration agreements.
Since the distributions are solely funded by the cash flows from the IP asset(s), the value of the
minority interest is equal in value to the IPR&D asset(s).
Summary
To summarize the above matters, we believe our accounting of these transactions reflects the
substance of the arrangements and the reporting provides investors with the meaningful information
provided by the principles outlined in the applicable literature. Under our reporting model, (1)
R&D expense over the course of these arrangements equals (and will continue to equal) the cash we
have paid (or will pay) to our collaboration counterparties, and (2) we have also consolidated the
IPR&D expense ($64 million through December 31, 2007) of the applicable counterparty for the total
fair value of the arrangements, which was entirely offset, through a separate line in our statement
of operations due to the minority interest holders owning 100% of the equity of the Subsidiaries.
4
An alternative reporting model might have been to net the minority interest benefit against the
IPR&D expense; however, we believe that approach would have provided less information to investors.
Further, reporting the transaction on such a net basis may have been viewed as artificially
circumventing the implications of consolidation under FIN 46(R).
***
The Company acknowledges that it is responsible for the adequacy and accuracy of the disclosures in
its filings with the Commission. The Company also acknowledges that the Staff comments or changes
to disclosure in response to Staff comments do not foreclose the Commission from taking any action
with respect to our filings and the Company may not assert Staff comments as a defense in any
proceeding initiated by the Commission or any person under the federal securities laws of the
United States.
Please call the undersigned at 617-679-2803 or Michael F. MacLean, Senior Vice President, Chief
Accounting Officer and Controller at 617-679-3973, if you have any questions regarding the matters
addressed in this letter or require any additional information.
|
|
|
|
|
|
Sincerely,
|
|
|
/s/ Paul J. Clancy
|
|
|
Paul J. Clancy |
|
|
Executive Vice President, Finance
and Chief Financial Officer |
|
|
5
EXHIBIT AAnalysis of our Disclosure for the Collaboration with Neurimmune SubOne.
Underlined material is additional disclosure to be included in our 2008 Form 10-K
|
|
|
|
|
FIN 46(R) |
|
Requested Disclosure |
|
Disclosure as provided in the 2007 |
Reference |
|
|
|
Form 10-K |
|
|
|
|
|
Paragraph 23a
|
|
Purpose of the
collaboration
agreement, including
the assets that will be
developed and the
contract period.
|
|
In November 2007, we
entered into a
collaboration agreement
with Neurimmune SubOne
AG, or Neurimmune, for
the worldwide
development and
commercialization of
human antibodies for
the treatment of
Alzheimers disease, or
AD. The collaboration
agreement is effective
for 12 years from the
first commercial sale
of a product using such
compound. |
|
|
|
|
|
Paragraph 23a
|
|
Services to be
delivered by each
party.
|
|
Neurimmune will conduct
research to identify
potential therapeutic
antibodies and we will
be responsible for the
development and
commercialization of
all products. |
|
|
|
|
|
Paragraph 23a
|
|
Rights and obligations
of each party.
The size of the
arrangement includes
the amount of
development costs,
discussed below, and
the amount of milestone
payments.
|
|
Under the terms of the
agreement, we paid a
$2.0 million upfront
payment and may pay up
to $378.0 million in
milestone payments, as
well as a royalty on
net sales of any
resulting commercial
products. We also will
reimburse Neurimmune
for research and
development costs
incurred. |
|
|
|
|
|
|
|
A description of our
accounting model.
|
|
We have determined that
we are the primary
beneficiary under FIN
46(R), because we are
required to fund 100%
of the development
costs under the
collaboration
agreement. As a
result, we have
consolidated the
results of Neurimmune
and recorded an IPR&D
charge of $34.3
million. The amount
allocated to IPR&D
relates to the
development of the
Beta-Amyloid antibody.
At the effective date
of the agreement, this
compound had not
reached technological
feasibility and had no
alternative future use.
We have allocated the
$34.3 million to the
minority interest, as
the charge represents
the fair value of the
Beta-Amyloid antibody
retained by the
minority interest
holders. As a result,
we have recorded a
credit in minority
interest, which is
recorded in other
income (expense). |
6
|
|
|
|
|
FIN 46(R) |
|
Requested Disclosure |
|
Disclosure as provided in the 2007 |
Reference |
|
|
|
Form 10-K |
|
|
|
|
|
Paragraph 23a
|
|
Size of the arrangement
includes the amount of
development costs and
the amount of milestone
payments, discussed
above.
|
|
Through December 31,
2007, we have spent an
additional $0.6 million
to develop the
Beta-Amyloid antibody.
We expect to incur
approximately an
additional $310 million
to develop the
Beta-Amyloid antibody
for all indications
under development. |
|
|
|
|
|
Paragraph 23a
|
|
Additional information
we deemed necessary for
the users of our
financial statements to
understand the
transaction.
|
|
The estimated revenues
from the Beta-Amyloid
antibody are expected
to be recognized
beginning in 2017. A
discount rate of 15%
was used to value this
project, which we
believe to be
commensurate with the
stage of development of
the Beta-Amyloid
antibody and the
uncertainties in the
economic estimates
described above. |
7
EXHIBIT A continued Analysis of our Disclosure for the Collaboration with Cardiokine Biopharma
LLC.
Underlined material is additional disclosure to be included in our 2008 Form 10-K.
|
|
|
|
|
FIN 46(R) |
|
Requested Disclosure |
|
Disclosure as provided in the 2007 |
Reference |
|
|
|
Form 10-K |
|
|
|
|
|
Paragraph 23a
|
|
Purpose of the
collaboration
agreement, including
the assets that will be
developed and the
contract period.
|
|
In August 2007, our
collaboration agreement
with Cardiokine
Biopharma LLC became
effective. The
agreement is for the
joint development of
lixivaptan, an oral
compound for the
potential treatment of
hyponatremia in
patients with
congestive heart
failure. The
collaboration agreement
is effective for 10
years from the first
commercial sale of a
product using such
compound. |
|
|
|
|
|
Paragraph 23a
|
|
Services to be
delivered by each
party.
|
|
We will be responsible
for the global
commercialization of
lixivaptan and
Cardiokine Biopharma
LLC has an option for
limited co-promotion in
the U.S. |
|
|
|
|
|
Paragraph 23a
|
|
Rights and obligations
of each party.
The size of the
arrangement includes
the amount of
development costs,
discussed below, and
the amount of milestone
payments.
|
|
Under the terms of the
agreement, we paid a
$50.0 million upfront
payment and will pay up
to $170.0 million in
milestone payments for
successful development
and global
commercialization of
lixivaptan, as well as
royalties on commercial
sales. The $50.0
million is reflected as
research and
development expense in
the accompanying
consolidated statement
of income. |
8
|
|
|
|
|
FIN 46(R) |
|
Requested Disclosure |
|
Disclosure as provided in the 2007 |
Reference |
|
|
|
Form 10-K |
|
|
|
|
|
|
|
A description of our
accounting model.
|
|
We have determined that
we are the primary
beneficiary under FIN
46(R), because we are
required to fund 90% of
the development costs
under the collaboration
agreement, while the
equity holders of
Cardiokine Biopharma
LLC are required to
fund only 10% of the
development costs. As
a result, we have
consolidated the
results of Cardiokine
Biopharma LLC and
recorded an IPR&D
charge of approximately
$30 million. The
amount allocated to
IPR&D relates to the
development of
lixivaptan. At the
effective date of the
agreement, this
compound had not
reached technological
feasibility and had no
alternative future use.
We have allocated the
approximately $30
million to the minority
interest, as the charge
represents the fair
value of the lixivaptan
compound retained by
the minority interest
holders. As a result,
we recorded a credit in
minority interest,
which is recorded in
other income (expense). |
|
|
|
|
|
Paragraph 23a
|
|
Size of the arrangement
includes the amount of
development costs and
the amount of milestone
payments, discussed
above.
|
|
Through December 31,
2007, we have spent an
additional $15.5
million to develop
lixivaptan since the
agreement became
effective. We expect
to incur approximately
an additional $260
million to develop
lixivaptan for all
indications under
development. |
|
|
|
|
|
Paragraph 23a
|
|
Additional information
we deemed necessary for
the users of our
financial statements to
understand the
transaction.
|
|
The estimated revenues
from lixivaptan are
expected to be
recognized beginning in
2011. A discount rate
of 11% was used to
value this project,
which we believe to be
commensurate with the
stage of development of
lixivaptan and the
uncertainties in the
economic estimates
described above. |
9