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SEC Comment Letter for IDM PHARMA, INC. (CIK 0000822206) — May 27, 2005

IDM PHARMA, INC. (CIK 0000822206)
Date: May 27, 2005 · CIK: 0000822206 · Accession: 0000000000-05-026289

AI Filing Summary & Sentiment

Date
May 20, 2005
Author
Not clearly detected
Form
UPLOAD
Company
IDM PHARMA, INC. (CIK 0000822206)

Letter

Emile Loria, M.D. President and Chief Executive Officer Epimmune Inc. 5820 Nancy Ridge Drive, San Diego, California 92121 Form 10-K for the year ended December 31, 2004 File No. 1-19591 Form 10-Q for the quarterly period ended March 31, 2005 File No. 1-19591

Re: Epimmune Inc. Preliminary Schedule 14A Filed April 22, 2005 File No. 1-19591

Dear Dr. Loria:

We have reviewed your filings and have the following comments. Where indicated, we think you should revise your documents in response to these comments. If you disagree, we will consider your explanation as to why a comment is inapplicable or a revision is unnecessary. Please be as detailed as necessary in your explanation. In some of our comments, we may ask you to provide us with supplemental information so we may better understand your disclosure. After reviewing this information, we may or may not raise additional comments.

Please understand that the purpose of our review process is to assist you in your compliance with the applicable disclosure requirements and to enhance the overall disclosure in your filing. We look forward to working with you in these respects. We welcome any questions you may have about our comments or any other aspect of our review. Feel free to call us at the telephone numbers listed at the end of this letter. Preliminary Schedule 14A General

1. Please note that where we provide examples to illustrate what we mean by our comments, they are examples only and not intended as exhaustive lists. If our comments are applicable to portions of your filing that we have not cited as examples, please make the appropriate changes in accordance with our comments. 2. In addition, please note that you are required to file with the Commission any written instructions, scripts, and outlines that will be used by any person that solicits proxies on behalf of Epimmune through personal interview, telephone, or telegram, and all other soliciting material that will be furnished to Epimmune shareholders. See Rules 14a-6(b) and (c) of the Exchange Act of 1934. 3. We note that the proxy card asks stockholders to grant the proxies discretionary authority to vote on any other matters that may properly come before the meeting. Please ensure that the proxy statement provides appropriate disclosure to Epimmune stockholders of this proxy authority. 4. To the extent that IDM received any financial information about Epimmune in the course of the parties` due diligence and negotiations that is not otherwise disclosed in the proxy statement or in Epimmune`s public filings, please consider whether such information should be disclosed in your next amendment to the proxy statement. In addition, please tell us by supplementary response whether you are aware of any such information and describe the nature of this information. Introductory Letter to Epimmune Stockholders

5. We note your statement that you are enclosing your annual report to stockholders for the year ended December 31, 2004 along with your proxy statement. In addition, you should also enclose a copy of your most recent quarterly report on Form 10-Q. Please confirm that you will comply with this request and revise your letter to stockholders accordingly. Notice of Annual Meeting of Stockholders 6. We note that the deadline for returning proxies appears on page of the proxy statement under the caption "How do I vote?" Please also include this deadline in the bolded legend at the bottom of the Notice.

7. You state that the transactions under the Share Exchange Agreement will not close if any of proposals 1, 3 or 4 do not receive the required vote by Epimmune stockholders unless the IDM shareholders who are parties to the Share Exchange Agreement waive this condition to consummation. However, we note that you are also seeking stockholder approval in accordance with the rules of the Nasdaq Stock Market regarding the issuance of shares of Epimmune`s common stock. Therefore, the Company should clarify that it is also seeking approval to comply with NASD requirements and that even if the IDM shareholders were to waive the requirement under the Share Exchange Agreement, without stockholder approval Epimmune would face the delisting of its shares on the Nasdaq Stock Market. Chapter 1 - Overview

Questions and Answers About the Exchange, pages 1-4 8. In addition to the matters already addressed in this section, please also include questions and answers about the following: * the percentage of outstanding common stock of the combined company that will be owned by each of the former (i) non-affiliates and (ii) affiliates of Epimmune, on a fully diluted basis; * whether the current holders of Epimmune derivative securities will be afforded the opportunity to vote the shares of common stock underlying their derivative securities for purposes of approving the merger; and * whether current holders of Epimmune derivative securities will be permitted to convert such holdings prior to the stockholders` meeting and, if so, the mechanics for doing so 9. On page 4, in your discussion of Epimmune stockholders that have committed to vote in favor of the transaction with IDM, please provide the percentage of outstanding Epimmune common stock, as of the record date, that has agreed to vote in this manner. 10. Please address, either in this section or in the Summary of the Exchange that begins on page 10, any material tax effects to Epimmune stockholders as a result of the Share Exchange Agreement and related transactions. If there are no material tax effects, please make this clear. 11. Similarly, please discuss any material tax effects to Epimmune as a result of the Share Exchange Agreement and related transactions. If there are none, you should state affirmatively that such is the case.

12. In the second paragraph under the caption "How are votes counted?" on page 8, please disclose which of each of the proposals being offered for shareholder consideration would be considered discretionary and which would be considered non-discretionary. In addition, we are unclear why the New York Stock Exchange rules are relevant in this case. Please explain or revise your disclosure, as appropriate. 13. On pages 8-9 under the caption "How many votes are needed to approve each proposal?," please clarify whether the preferred stockholders vote as a single class with the common or separately. 14. On page 12 under the caption "Interests of Directors, Officers and Affiliates," please disclose the number of options that will vest in full for each of the three officers and the number of options for the three members of the Board that will remain exercisable. Similarly, the disclosure that appears in the bullet points on pages 19-20 under the risk factor entitled "Some of the directors and executive officers of Epimmune and IDM may have interests in the Exchange that are different from . . .," should be more specific. For example, in the second bullet point, you should state the number of options that will vest in full for each person. As another example, in the fourth bullet point, please state the actual dollar amount of each cash bonus.

Risk Factors, pages 19-36 General 15. Where you lay out bullet points highlighting specific risk factors, please elaborate on any specific problems you have faced in the past relating to those bullet points, are ongoing, or which are likely to occur. Please note that in doing so, your resulting disclosure might become significant enough to warrant a separate risk factor. We may have further comments on your disclosure. 16. If either Epimmune or IDM has material agreements that, by their terms, may be terminated or renegotiated as a result of the transactions described in the proxy statement, or cannot be assumed by the combined company without undue difficulty, please add a separate risk factor that addresses this point. You should also disclose whether any third party has indicated its intention to terminate its agreement with either company or to defer or delay a decision affecting its agreement with either company in response to the contemplated transactions. We note, for instance, the risk factor entitled "The combined company may not be able to obtain licenses . . ." on page 27 which discloses that "certain license agreements to which IDM is a party may not be transferred to the combined company without the licensor`s consent . . ." 17. We note that the indemnity escrow shares will be the sole and exclusive remedy of Epimmune and its affiliates for any losses arising out of any claims relating to the Share Exchange Agreement. We refer page 71 of the proxy statement. Please consider whether this limitation of liability presents a material transaction risk that should be disclosed as a separate risk factor. If the Epimmune board considered this feature of the Share Exchange Agreement as a negative factor weighing against the transaction with IDM, this should also be disclosed as appropriate in the proxy statement. 18. Please consider whether there is a need for a risk factor that addresses the diminution of voting control by former holders of Epimmune as a result of the conversion of their stake in Epimmune to ownership of an interest in the combined company. In other words, the shares in the combined company held by former Epimmune holders as a group will no longer equate to a controlling interest in the surviving company (as they once did with respect to Epimmune), nor will each individual Epimmune holder exert the same degree of voting power with respect to the combined company that it did with Epimmune prior to the consummation of the transactions. 19. There appears to be a considerable amount of unnecessary redundancy throughout your risk factors, especially with respect to your discussion of the risks associated with the development and commercialization of the companies` product candidates. By way of example only:

* The risk factors entitled "If the combined company does not successfully develop and commercialize its products . . . (pages 28- 29)," "The combined company will be subject to extensive and uncertain government regulation . . . (page 29)" and "The lengthy approval process and uncertainty of U.S. and European government regulatory requirements . . . (pages 29-30)," are largely duplicative of the risk factors entitled "IDM`s lead product candidate Mepact, may never obtain regulatory approval (page 21)" and "The process of developing immunotherapeutic products . . . (page 22);"

* The risk factors entitled "The combined company will be at an early stage of development . . . (page 25)" is duplicative of the risk factor entitled "The process of developing immunotherapeutic products . . . (page 22);"

* The risk factor entitled "Product liability risks may expose the combined company to significant liability . . . (pages 34-35)" is duplicative of the risk factor entitled "Unexpected or undesirable side effects or other characteristics of the combined company`s technology . . . (page 25);"

* The risk factor entitled "The combined company`s treatment approach may not prove effective (page 26)" is duplicative of the risk factor entitled "The combined company`s research and development programs may not yield effective product candidates . . . (pages 25-26);"

* The risk factor entitled "If the combined company is unable to compete effectively . . ." is duplicative of the risk factor entitled "The combined company`s competitors may develop products that are more effective . . . (page 31);" and

* The risk factor entitled "Uncertain third-party reimbursement and health care reform measures may delay market acceptance . . . (page 34)" is duplicative of the risk factor entitled "Successful commercialization of future products of the combined company will depend on its ability to gain acceptance . . . (pages 33-34)"

Risks Related to the Business of the Combined Company, pages 21-

"Some of our research and development programs are funded by the U.S. government . . . ," page 22 20. Please disclose the extent to which such programs are exclusively funded by the U.S. government and the percent of the combined company`s revenue attributable to such funding.

"IDM`s principal source of revenues and operating cash flows . . .," pages 22-23 21. Please disclose the percent of the combined company`s revenue and operating cash flow that would have been attributable to Sanofi- Aventis S.A. for the years 2002, 2003 and 2004.

"Epimmune`s and IDM`s history of operating losses . . .," pages 23-24 22. Please revise to disclose each company`s cumulative losses since inception and losses in each of the last three completed fiscal years.

"The combined company may experience difficulties managing its growth . . .," page 25 23. Your description in this risk factor could apply to any company in any industry. The discussion should be honed so that it is specific to your company and describes with particularity why the combined company is vulnerable to the risk presented. Please revise accordingly. See Item 503(c) of Regulation S-K.

"The combined company`s supplies of certain materials . . .," page 24. Please disclose the extent to which: * any of the critical materials supplied by third parties are not readily obtainable from alternate vendors; and

* these materials are supplied pursuant to long-term contracts. 25. Please also address whether any of the key raw materials used by the two companies are inherently scarce and the risks this may pose.

"If the combined company loses its key scientific and management personnel . . .," page 33 26. Since most companies rely on their key personnel, clearly explain how this specific risk factor applies to your company. For example, identify the key personnel upon whom you are dependent and how you would be specifically adversely affected if one or more of them left. 27. Please disclose whether you have reason to believe that key employees will depart the companies as a result of the impending transaction or, independent of the transaction, any individuals are planning to leave, retire or are nearing retirement age. If so, please identify such and the anticipated impact on the combined company going forward. 28. Please disclose whether you have employment contracts with your key scientific and management personnel and those contracts are affected, if at all, by the contemplated transactions.

"Product liability risks may expose the combined company to significant liability . . .," pages 34-35 29. Please discuss the extent to which the combined company has received commitments in respect of product liability insurance.

"The combined company`s use of hazardous materials...," page 35 30. Please be more specific about the hazardous materials that you use in your business. In addition, state whether the combined company anticipates carrying liability insurance for contamination or injury resulting from the use of hazardous materials.

Risks Related to Our Common Stock, pages 35-26

"Future sales of shares of our common stock . . .," page 36 31. Please disclose the number of shares (including those underlying derivative securities) in the combined company that will be eligible for sale in the public markets following expiration of the six- month lock-up agreement.

Chapter Two - Proposal 1

Background of the Exchange, pages 37-46

General 32. Please provide us supplementally with copies of any non-public information - documents, financial forecasts, projections and presentations - used by or on behalf of Epimmune in the merger negotiations and any schedules and attachments to the merger agreement that were not filed with the registration statement. We may have additional comments. 33. Please provide us supplementally with all of the materials, including any financial analyses, used by

Show Raw Text
<DOCUMENT>
<TYPE>LETTER
<SEQUENCE>1
<FILENAME>filename1.txt
<TEXT>

Mail Stop 6010

      							May 20, 2005

Emile Loria, M.D.
President and Chief Executive Officer
Epimmune Inc.
5820 Nancy Ridge Drive,
San Diego, California 92121

Re:	Epimmune Inc.
	Preliminary Schedule 14A
      Filed April 22, 2005
      File No. 1-19591

   Form 10-K for the year ended December 31, 2004
	File No. 1-19591

	Form 10-Q for the quarterly period ended March 31, 2005
	File No. 1-19591

Dear Dr. Loria:

      We have reviewed your filings and have the following
comments.
Where indicated, we think you should revise your documents in
response to these comments.  If you disagree, we will consider
your
explanation as to why a comment is inapplicable or a revision is
unnecessary.  Please be as detailed as necessary in your
explanation.
In some of our comments, we may ask you to provide us with
supplemental information so we may better understand your
disclosure.
After reviewing this information, we may or may not raise
additional
comments.

      Please understand that the purpose of our review process is
to
assist you in your compliance with the applicable disclosure
requirements and to enhance the overall disclosure in your filing.
We look forward to working with you in these respects.  We welcome
any questions you may have about our comments or any other aspect
of
our review.  Feel free to call us at the telephone numbers listed
at
the end of this letter.
Preliminary Schedule 14A
General

1. Please note that where we provide examples to illustrate what
we
mean by our comments, they are examples only and not intended as
exhaustive lists.  If our comments are applicable to portions of
your
filing that we have not cited as examples, please make the
appropriate changes in accordance with our comments.
2. In addition, please note that you are required to file with the
Commission any written instructions, scripts, and outlines that
will
be used by any person that solicits proxies on behalf of Epimmune
through personal interview, telephone, or telegram, and all other
soliciting material that will be furnished to Epimmune
shareholders.
See Rules 14a-6(b) and (c) of the Exchange Act of 1934.
3. We note that the proxy card asks stockholders to grant the
proxies
discretionary authority to vote on any other matters that may
properly come before the meeting.  Please ensure that the proxy
statement provides appropriate disclosure to Epimmune stockholders
of
this proxy authority.
4. To the extent that IDM received any financial information about
Epimmune in the course of the parties` due diligence and
negotiations
that is not otherwise disclosed in the proxy statement or in
Epimmune`s public filings, please consider whether such
information
should be disclosed in your next amendment to the proxy statement.
In addition, please tell us by supplementary response whether you
are
aware of any such information and describe the nature of this
information.
Introductory Letter to Epimmune Stockholders

5. We note your statement that you are enclosing your annual
report
to stockholders for the year ended December 31, 2004 along with
your
proxy statement.  In addition, you should also enclose a copy of
your
most recent quarterly report on Form 10-Q.  Please confirm that
you
will comply with this request and revise your letter to
stockholders
accordingly.
Notice of Annual Meeting of Stockholders
6. We note that the deadline for returning proxies appears on page
6
of the proxy statement under the caption "How do I vote?"  Please
also include this deadline in the bolded legend at the bottom of
the
Notice.

7. You state that the transactions under the Share Exchange
Agreement
will not close if any of proposals 1, 3 or 4 do not receive the
required vote by Epimmune stockholders unless the IDM shareholders
who are parties to the Share Exchange Agreement waive this
condition
to consummation.  However, we note that you are also seeking
stockholder approval in accordance with the rules of the Nasdaq
Stock
Market regarding the issuance of shares of Epimmune`s common
stock.
Therefore, the Company should clarify that it is also seeking
approval to comply with NASD requirements and that even if the IDM
shareholders were to waive the requirement under the Share
Exchange
Agreement, without stockholder approval Epimmune would face the
delisting of its shares on the Nasdaq Stock Market.
Chapter 1 - Overview

Questions and Answers About the Exchange, pages 1-4
8. In addition to the matters already addressed in this section,
please also include questions and answers about the following:
* the percentage of outstanding common stock of the combined
company
that will be owned by each of the former (i) non-affiliates and
(ii)
affiliates of Epimmune, on a fully diluted basis;
* whether the current holders of Epimmune derivative securities
will
be afforded the opportunity to vote the shares of common stock
underlying their derivative securities for purposes of approving
the
merger; and
* whether current holders of Epimmune derivative securities will
be
permitted to convert such holdings prior to the stockholders`
meeting
and, if so, the mechanics for doing so
9. On page 4, in your discussion of Epimmune stockholders that
have
committed to vote in favor of the transaction with IDM, please
provide the percentage of outstanding Epimmune common stock, as of
the record date, that has agreed to vote in this manner.
10. Please address, either in this section or in the Summary of
the
Exchange that begins on page 10, any material tax effects to
Epimmune
stockholders as a result of the Share Exchange Agreement and
related
transactions.  If there are no material tax effects, please make
this
clear.
11. Similarly, please discuss any material tax effects to Epimmune
as
a result of the Share Exchange Agreement and related transactions.
If there are none, you should state affirmatively that such is the
case.

12. In the second paragraph under the caption "How are votes
counted?" on page 8, please disclose which of each of the
proposals
being offered for shareholder consideration would be considered
discretionary and which would be considered non-discretionary.  In
addition, we are unclear why the New York Stock Exchange rules are
relevant in this case.  Please explain or revise your disclosure,
as
appropriate.
13. On pages 8-9 under the caption  "How many votes are needed to
approve each proposal?," please clarify whether the preferred
stockholders vote as a single class with the common or separately.
14. On page 12 under the caption "Interests of Directors, Officers
and Affiliates," please disclose the number of options that will
vest
in full for each of the three officers and the number of options
for
the three members of the Board that will remain exercisable.
Similarly, the disclosure that appears in the bullet points on
pages
19-20 under the risk factor entitled "Some of the directors and
executive officers of Epimmune and IDM may have interests in the
Exchange that are different from . . .," should be more specific.
For example, in the second bullet point, you should state the
number
of options that will vest in full for each person.  As another
example, in the fourth bullet point, please state the actual
dollar
amount of each cash bonus.

Risk Factors, pages 19-36
General
15. Where you lay out bullet points highlighting specific risk
factors, please elaborate on any specific problems you have faced
in
the past relating to those bullet points, are ongoing, or which
are
likely to occur.  Please note that in doing so, your resulting
disclosure might become significant enough to warrant a separate
risk
factor.  We may have further comments on your disclosure.
16. If either Epimmune or IDM has material agreements that, by
their
terms, may be terminated or renegotiated as a result of the
transactions described in the proxy statement,  or cannot be
assumed
by the combined company without undue difficulty, please add a
separate risk factor that addresses this point.  You should also
disclose whether any third party has indicated its intention to
terminate its agreement with either company or to defer or delay a
decision affecting its agreement with either company in response
to
the contemplated transactions.  We note, for instance, the risk
factor entitled "The combined company may not be able to obtain
licenses . . ."  on page 27 which discloses that "certain license
agreements to which IDM is a party may not be transferred to the
combined company without the licensor`s consent . . ."
17. We note that the indemnity escrow shares will be the sole and
exclusive remedy of Epimmune and its affiliates for any losses
arising out of any claims relating to the Share Exchange
Agreement.
We refer page 71 of the proxy statement.  Please consider whether
this limitation of liability presents a material transaction risk
that should be disclosed as a separate risk factor.  If the
Epimmune
board considered this feature of the Share Exchange Agreement as a
negative factor weighing against the transaction with IDM, this
should also be disclosed as appropriate in the proxy statement.
18. Please consider whether there is a need for a risk factor that
addresses the diminution of voting control by former holders of
Epimmune as a result of the conversion of their stake in Epimmune
to
ownership of an interest in the combined company.  In other words,
the shares in the combined company held by former Epimmune holders
as
a group will no longer equate to a controlling interest in the
surviving company (as they once did with respect to Epimmune), nor
will each individual Epimmune holder exert the same degree of
voting
power with respect to the combined company that it did with
Epimmune
prior to the consummation of the transactions.
19. There appears to be a considerable amount of unnecessary
redundancy throughout your risk factors, especially with respect
to
your discussion of the risks associated with the development and
commercialization of the companies` product candidates.  By way of
example only:

* The risk factors entitled "If the combined company does not
successfully develop and commercialize its products . . . (pages
28-
29)," "The combined company will be subject to extensive and
uncertain government regulation . . . (page 29)" and "The lengthy
approval process and uncertainty of U.S. and European government
regulatory requirements . . . (pages 29-30)," are largely
duplicative
of the risk factors entitled "IDM`s lead product candidate Mepact,
may never obtain regulatory approval (page 21)" and "The process
of
developing immunotherapeutic products
. . . (page 22);"

* The risk factors entitled "The combined company will be at an
early
stage of development . . . (page 25)" is duplicative of the risk
factor entitled "The process of developing immunotherapeutic
products
. . . (page 22);"

* The risk factor entitled "Product liability risks may expose the
combined company to significant liability . . . (pages 34-35)" is
duplicative of the risk factor entitled "Unexpected or undesirable
side effects or other characteristics of the combined company`s
technology . . . (page 25);"

* The risk factor entitled "The combined company`s treatment
approach
may not prove effective (page 26)" is duplicative of the risk
factor
entitled "The combined company`s research and development programs
may not yield effective product candidates . . . (pages 25-26);"

* The risk factor entitled "If the combined company is unable to
compete effectively
. . ." is duplicative of the risk factor entitled "The combined
company`s competitors may develop products that are more effective
.
. . (page 31);" and

* The risk factor entitled "Uncertain third-party reimbursement
and
health care reform measures may delay market acceptance . . .
(page
34)" is duplicative of the risk factor entitled "Successful
commercialization of future products of the combined company will
depend on its ability to gain acceptance . . . (pages 33-34)"

  Risks Related to the Business of the Combined Company, pages 21-
35

"Some of our research and development programs are funded by the
U.S.
government . . . ," page 22
20. Please disclose the extent to which such programs are
exclusively
funded by the U.S. government and the percent of the combined
company`s revenue attributable to such funding.

"IDM`s principal source of revenues and operating cash flows . .
.,"
pages 22-23
21. Please disclose the percent of the combined company`s revenue
and
operating cash flow that would have been attributable to Sanofi-
Aventis S.A. for the years 2002, 2003 and 2004.

"Epimmune`s and IDM`s history of operating losses . . .," pages
23-24
22. Please revise to disclose each company`s cumulative losses
since
inception and losses in each of the last three completed fiscal
years.

"The combined company may experience difficulties managing its
growth
. . .," page 25
23. Your description in this risk factor could apply to any
company
in any industry.  The discussion should be honed so that it is
specific to your company and describes with particularity why the
combined company is vulnerable to the risk presented.   Please
revise
accordingly.  See Item 503(c) of Regulation S-K.

"The combined company`s supplies of certain materials . . .," page
27
24. Please disclose the extent to which:
* any of the critical materials supplied by third parties are not
readily obtainable from alternate vendors; and

* these materials are supplied pursuant to long-term contracts.
25. Please also address whether any of the key raw materials used
by
the two companies are inherently scarce and the risks this may
pose.

"If the combined company loses its key scientific and management
personnel . . .," page 33
26. Since most companies rely on their key personnel, clearly
explain
how this specific risk factor applies to your company.  For
example,
identify the key personnel upon whom you are dependent and how you
would be specifically adversely affected if one or more of them
left.
27. Please disclose whether you have reason to believe that key
employees will depart the companies as a result of the impending
transaction or, independent of the transaction, any individuals
are
planning to leave, retire or are nearing retirement age. If so,
please identify such and the anticipated impact on the combined
company going forward.
28. Please disclose whether you have employment contracts with
your
key scientific and management personnel and those contracts are
affected, if at all, by the contemplated transactions.

"Product liability risks may expose the combined company to
significant liability . . .," pages 34-35
29. Please discuss the extent to which the combined company has
received commitments in respect of product liability insurance.

"The combined company`s use of hazardous materials...," page 35
30. Please be more specific about the hazardous materials that you
use in your business.  In addition, state whether the combined
company anticipates carrying liability insurance for contamination
or
injury resulting from the use of hazardous materials.

Risks Related to Our Common Stock, pages 35-26

"Future sales of shares of our common stock . . .," page 36
31. Please disclose the number of shares (including those
underlying
derivative securities) in the combined company that will be
eligible
for sale in the public markets following expiration of the six-
month
lock-up agreement.

Chapter Two - Proposal 1

Background of the Exchange, pages 37-46

General
32. Please provide us supplementally with copies of any non-public
information - documents, financial forecasts, projections and
presentations - used by or on behalf of Epimmune in the merger
negotiations and any schedules and attachments to the merger
agreement that were not filed with the registration statement.  We
may have additional comments.
33. Please provide us supplementally with all of the materials,
including any financial analyses, used by