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SEC Company Response from REGENERON PHARMACEUTICALS, INC. (REGN) (CIK 0000872589) (REGN) — May 29, 2007

REGENERON PHARMACEUTICALS, INC. (REGN) (CIK 0000872589)
Date: May 29, 2007 · CIK: 0000872589 · Accession: 0001341004-07-001713

AI Filing Summary & Sentiment

File numbers found in text: 000-19034

Date
May 29, 2007
Author
Not clearly detected
Form
CORRESP
Company
REGENERON PHARMACEUTICALS, INC. (REGN) (CIK 0000872589)

Letter

Securities and Exchange Commission Division of Corporation Finance RE: Regeneron Pharmaceuticals, Inc. Form 10-K for the fiscal year ended December 31, 2006 File No. 000-19034

Dear Mr. Rosenberg:

This letter sets forth the responses of Regeneron Pharmaceuticals, Inc., a New York corporation (the “Company”), to the comments of the staff of the Securities and Exchange Commission (the “Staff”) set forth in the Staff’s letter of May 10, 2007 (the “Comment Letter”) to Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of the Company, regarding the above-referenced annual report on Form 10-K (the “Annual Report”). For the convenience of the Staff, we have restated in this letter each of the comments in the Comment Letter and numbered each of the responses to correspond with the numbers of the comments in the Comment Letter. Capitalized terms used and not defined regarding the Annual Report have the meanings given in the Annual Report. All references to page numbers and captions correspond to the page numbers and captions in the Annual Report.

Form 10-K for the year ended December 31, 2006

Management’s Discussion and Analysis of Financial Condition and Results of Operations

Research and Development Expenses, page 36

1.

We believe your disclosure related to research and development expenses could be improved by separately quantifying costs incurred for your product candidates, principally VEGF Trap-Oncology, VEGF Trap-Eye and IL-1 Trap and provide information that would allow investors to determine the reasonably likely timing for commercialization of your lead drug candidates and related revenue generation. Please provide in disclosure-type format the

Mr. Jim B. Rosenberg

Senior Assistant Chief Accountant

Securities and Exchange Commission

Page 2

following information for each of your major research and development projects. Refer to the Division of Corporation Finance “Current Issues and Rulemaking Projects Quarterly Update” under section VIII – Industry Specific Issues – Accounting and Disclosure by Companies Engaged in Research and Development Activities. You can find it at the following website address: http://www.sec.gov/divisions/corpfin/cfcrq032001.hmt#secviii

a.

The costs incurred during each period presented and to date on the project;

b.

The nature, timing and estimated costs of the efforts necessary to complete the project;

c.

The anticipated completion date for the project;

d.

The risks and uncertainties associated with completing development on schedule, and the consequences to operations, financial position and liquidity if the project is not completed timely; and,

e.

The period in which material net cash inflows from the project are expected to commence.

Regarding “a,” if you do not maintain any research and development costs by project, explain why management does not maintain and evaluate research and development costs by project. Provide other quantitative or qualitative disclosure that indicates the amount of the company’s resources being used on the project.

Regarding “b” and “c,” provide the amount or range of estimated costs and timing to complete the phase in the process and each future phase. To the extent that information is not estimable, describe those facts and circumstances indicating the uncertainties that prelude you from making a reasonable estimate.

The Company acknowledges the Staff’s comment. We disclosed on pages 36 and 37 of the Annual Report the major categories of our research and development expenses and primary causes of year to year fluctuations in the principal cost components of research and development expenses for the periods presented. This discussion included references to the clinical programs for our lead product candidates. In future filings, we will expand our discussion of research and development expenses to address the issues in “a” through “e” above to the extent appropriate. We have provided estimates of research and development costs for clinical development programs for 2006 and 2005. Cumulative costs for projects from inception are not available, as we do not compile full project costs for projects in discovery or preclinical stages. Our disclosure would be supplemented substantially as follows:

Mr. Jim B. Rosenberg

Senior Assistant Chief Accountant

Securities and Exchange Commission

Page 3

Drug development and approval in the United States is a multi-step process regulated by the FDA. The process begins with discovery and preclinical evaluation, leading up to the submission of an IND to the FDA which, if successful, allows the opportunity for study in humans, or clinical study, of the potential new drug. Clinical development typically involves three phases of study: Phase 1, 2 and 3. The most significant costs in clinical development are in Phase 3 clinical trials, as they tend to be the longest and largest studies in the drug development process. Following successful completion of Phase 3 clinical trials for a biological product, a biologics license application (or BLA) must be submitted to, and accepted by, the FDA, and the FDA must approve the BLA prior to commercialization of the drug. It is not uncommon for the FDA to request additional data following its review of a BLA, which can significantly increase the drug development timeline and expenses. We may elect either on our own, or at the request of the FDA, to conduct further studies that are referred to as Phase 3B and 4 studies. Phase 3B studies are initiated and either completed or substantially completed while the BLA is under FDA review. These studies are conducted under an IND. Phase 4 studies, also referred to as post-marketing studies, are studies that are initiated and conducted after the FDA has approved a product for marketing. In addition, as discovery research, preclinical development, and clinical programs progress, opportunities to expand development of drug candidates into new disease indications can emerge. We may elect to add such new disease indications to our development efforts (with the approval of our collaborator for joint development programs), thereby extending the period during which we will be developing a product. For example, we, and our collaborators, where applicable, continue to explore further development of the IL-1 Trap, VEGF Trap, and VEGF Trap-Eye in different disease indications.

There are numerous uncertainties associated with drug development, including uncertainties related to safety and efficacy data from each phase of drug development, uncertainties related to the enrollment and performance of clinical trials, changes in regulatory requirements, changes in the competitive landscape affecting a product candidate, and other risks and uncertainties described under “Risk Factors -- Risks Related to Development of our Product Candidates,” “--Regulatory and Litigation Risks”, and “--Risks Related to Commercialization of Products.” The lengthy process of seeking FDA approvals, and subsequent compliance with applicable statutes and regulations, require the expenditure of substantial resources. Any failure by us to obtain, or delay in obtaining, regulatory approvals could materially adversely affect our business. We cannot assure you that we will obtain any approval required by the FDA on a timely basis, if at all.

Mr. Jim B. Rosenberg

Senior Assistant Chief Accountant

Securities and Exchange Commission

Page 4

We budget our research and development costs by expense category, rather than by project. We also prepare estimates of research and development costs for projects in clinical development, which include direct costs and allocations of certain costs such as indirect labor, non-cash stock-based employee compensation expense related to stock option awards, and manufacturing and other costs related to activities that benefit multiple projects. Our estimates of research and development costs for clinical development programs are shown below:

(In millions)

Year ended December 31,

Project Costs

Increase

(Decrease)

VEGF Trap – Oncology

$30.7

$27.8

$2.9

VEGF Trap- Eye

21.9

9.3

12.6

IL-1 Trap

29.6

57.2

(27.6)

Other research programs & unallocated costs

54.9

61.3

(6.4)

Total research and development expenses

$137.1

$155.6

($18.5)

For the reasons described above and due to the variability in the costs necessary to develop a product, the uncertainties related to future indications to be studied, the estimated cost and scope of the projects, and uncertainty as to our ultimate ability to obtain governmental approval for commercialization, accurate and meaningful estimates of the total cost to bring our product candidates to market are not available. Similarly, we are currently unable to reasonably estimate if our product candidates will generate product revenues and material net cash inflows. We plan to submit a BLA for our IL-1 Trap for the treatment of CAPS, a spectrum of rare genetic disorders, in the second quarter of 2007. We cannot predict whether or when the commercialization of the IL-1 Trap in CAPS will result in a material net cash inflow to the company.

Funding Requirements, page 44

2.

Please explain in disclosure-type format your basis for omitting estimated payments from the table of contractual obligations that appear reasonably likely to arise from your research and development agreements with sanofi-aventis and Bayer Healthcare LLC. Discuss how profitability will be measured, your expected timing for achieving profitability and payment of development expense reimbursements if the collaborations are profitable.

The Company advises the Staff that under our research and development agreement with sanofi-aventis, the Company will be obligated to reimburse sanofi-aventis for 50% of the development expenses incurred by both companies out of our share of any future profits generated by the collaboration. We will repay sanofi-aventis for these development expenses in accordance with a formula based on the amount of development expenses incurred under the research and

Mr. Jim B. Rosenberg

Senior Assistant Chief Accountant

Securities and Exchange Commission

Page 5

development agreement and our share of profits generated in a calendar quarter. We disclosed this obligation in the Annual Report on page 42 (see “Liquidity and Capital Resources -- Collaboration with the sanofi-aventis Group”) and on page 30 (see “Collaborations -- The sanofi-aventis Group”).

We are unable to estimate development costs over the term of the sanofi-aventis arrangement which would be subject to reimbursement. These reimbursements are contingent contractual obligations which are predicated on the collaboration becoming profitable. In addition, the Company will not be required to make payments to sanofi-aventis to satisfy this reimbursement obligation. Rather, the reimbursement will be deducted from payments the Company would have otherwise been entitled to receive from sanofi-aventis out of our share of the collaboration’s profits, assuming that profitability is achieved. If profitability is never achieved, we will have no obligation to reimburse sanofi-aventis.

The Company also advises the Staff that under our research and development agreement with Bayer HealthCare, agreed upon VEGF Trap-Eye development expenses incurred by both companies, beginning in 2007, under a global development plan will be shared, as described in the Annual Report (see page reference below). If the collaboration becomes profitable, the Company will be obligated to reimburse Bayer HealthCare for 50% of Bayer HealthCare’s share of the VEGF Trap-Eye development expenses out of our share of the collaboration profits. We disclosed this obligation in the Annual Report on page 43 (see “Liquidity and Capital Resources -- Collaboration with Bayer Healthcare”) and on page 31 (see “Collaborations -- Bayer Healthcare LLC”).

We are unable to estimate development costs over the term of the Bayer HealthCare arrangement which would be subject to reimbursement. These reimbursements are contingent contractual obligations which are predicated on the collaboration becoming profitable. In addition, the Company will not be required to make payments to Bayer HealthCare to satisfy this reimbursement obligation. Rather, the reimbursement will be deducted from payments the Company would have otherwise been entitled to receive from Bayer HealthCare out of our share of the collaboration’s profits, assuming that profitability is ever achieved. If profitability is never achieved, we will have no obligation to reimburse Bayer HealthCare.

The Company acknowledges the Staff’s comment. In future filings, we will expand our discussion under “Funding Requirements” to explain why the contingent contractual obligations for reimbursement of development expenses incurred by sanofi-aventis and Bayer HealthCare have been omitted from the table of contractual obligations. Our disclosure would be supplemented substantially as follows:

Mr. Jim B. Rosenberg

Senior Assistant Chief Accountant

Securities and Exchange Commission

Page 6

As described above under “Collaboration with Bayer Healthcare”, over the next several years we and Bayer Healthcare are sharing agreed-upon VEGF Trap-Eye development expenses.

In addition, as described above under “Collaboration with the sanofi-aventis Group” and “Collaboration with Bayer Healthcare”, if the applicable collaboration becomes profitable, we have contingent contractual obligations to reimburse sanofi-aventis and Bayer Healthcare for 50% of agreed-upon development expenses incurred by sanofi-aventis and Bayer Healthcare, respectively. Profitability under each collaboration will be measured by calculating net sales less agreed-upon expenses. These reimbursements will be deducted from our share of the collaboration profits and, for sanofi-aventis, royalties otherwise payable to us based on product sales in Japan, unless we agree to reimburse these expenses at a faster rate at our option. Given the uncertainties related to drug development (including the development of the VEGF Trap-Oncology in collaboration with sanofi-aventis and the VEGF Trap-Eye in collaboration with Bayer Healthcare) such as the variability in the length of time necessary to develop a product candidate and the ultimate ability to obtain governmental approval for commercialization, we are currently unable to reliably estimate if our collaborations with sanofi-aventis and Bayer Healthcare will become profitable.

Critical Accounting Policies and Significant Judgments and Estimates

Revenue Recognition, page 46

3.

You do not appear to have discussed the variability implicit in critical accounting estimates associated with your revenue recognition of contract research and development and research progress payments. Your disclosure should provide investors with a fuller understanding of the uncertainties in applying critical accounting estimates and the likelihood that materially different amounts would be reported under different conditions or using different assumptions. It should include quantification of the related variability in operating results that you expect to be reasonably likely to occur. Please describe in disclosure-type format the expected uncertainties and variability implicit in critical accounting estimates associated with your revenue recognition of these payments, the effect that changes in such estimates have had on your financial statements for each period presented, and the effect that reasonably likely changes in the key assumptions underlying these estimates may have on your financial statements in the future. Also, explain your basis for concluding that research and development activities other than clinical trial expenses do not involv

Show Raw Text
CORRESP
1
filename1.htm

May 29, 2007

BY EDGAR

Mr. Jim B. Rosenberg

Senior Assistant Chief Accountant

Securities and Exchange Commission

Division of Corporation Finance

Mail Stop 6010

100 F Street, NE

Washington, D.C. 20549

RE:

Regeneron Pharmaceuticals, Inc.

Form 10-K for the fiscal year ended December 31, 2006

File No. 000-19034

Dear Mr. Rosenberg:

This letter sets forth the responses of Regeneron Pharmaceuticals, Inc., a New York corporation (the “Company”), to the comments of the staff of the Securities and Exchange Commission (the “Staff”) set forth in the Staff’s letter of May 10, 2007 (the “Comment Letter”) to Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of the Company, regarding the above-referenced annual report on Form 10-K (the “Annual Report”). For the convenience of the Staff, we have restated in this letter each of the comments in the Comment Letter and numbered each of the responses to correspond with the numbers of the comments in the Comment Letter. Capitalized terms used and not defined regarding the Annual Report have the meanings given in the Annual Report. All references to page numbers and captions correspond to the page numbers and captions in the Annual
Report.

Form 10-K for the year ended December 31, 2006

Management’s Discussion and Analysis of Financial Condition and Results of Operations

Research and Development Expenses, page 36

1.

We believe your disclosure related to research and development expenses could be improved by separately quantifying costs incurred for your product candidates, principally VEGF Trap-Oncology, VEGF Trap-Eye and IL-1 Trap and provide information that would allow investors to determine the reasonably likely timing for commercialization of your lead drug candidates and related revenue generation. Please provide in disclosure-type format the

Mr. Jim B. Rosenberg

Senior Assistant Chief Accountant

Securities and Exchange Commission

Page 2

following information for each of your major research and development projects. Refer to the Division of Corporation Finance “Current Issues and Rulemaking Projects Quarterly Update” under section VIII – Industry Specific Issues – Accounting and Disclosure by Companies Engaged in Research and Development Activities. You can find it at the following website address: http://www.sec.gov/divisions/corpfin/cfcrq032001.hmt#secviii

a.

The costs incurred during each period presented and to date on the project;

b.

The nature, timing and estimated costs of the efforts necessary to complete the project;

c.

The anticipated completion date for the project;

d.

The risks and uncertainties associated with completing development on schedule, and the consequences to operations, financial position and liquidity if the project is not completed timely; and,

e.

The period in which material net cash inflows from the project are expected to commence.

Regarding “a,” if you do not maintain any research and development costs by project, explain why management does not maintain and evaluate research and development costs by project. Provide other quantitative or qualitative disclosure that indicates the amount of the company’s resources being used on the project.

Regarding “b” and “c,” provide the amount or range of estimated costs and timing to complete the phase in the process and each future phase. To the extent that information is not estimable, describe those facts and circumstances indicating the uncertainties that prelude you from making a reasonable estimate.

The Company acknowledges the Staff’s comment. We disclosed on pages 36 and 37 of the Annual Report the major categories of our research and development expenses and primary causes of year to year fluctuations in the principal cost components of research and development expenses for the periods presented. This discussion included references to the clinical programs for our lead product candidates. In future filings, we will expand our discussion of research and development expenses to address the issues in “a” through “e” above to the extent appropriate. We have provided estimates of research and development costs for clinical development programs for 2006 and 2005. Cumulative costs for projects from inception are not available, as we do not compile full project costs for projects in discovery or preclinical stages. Our disclosure would be supplemented substantially as
follows:

Mr. Jim B. Rosenberg

Senior Assistant Chief Accountant

Securities and Exchange Commission

Page 3

Drug development and approval in the United States is a multi-step process regulated by the FDA. The process begins with discovery and preclinical evaluation, leading up to the submission of an IND to the FDA which, if successful, allows the opportunity for study in humans, or clinical study, of the potential new drug. Clinical development typically involves three phases of study: Phase 1, 2 and 3. The most significant costs in clinical development are in Phase 3 clinical trials, as they tend to be the longest and largest studies in the drug development process. Following successful completion of Phase 3 clinical trials for a biological product, a biologics license application (or BLA) must be submitted to, and accepted by, the FDA, and the FDA must approve the BLA prior to commercialization of the drug. It is not uncommon for the FDA to request additional data following its
review of a BLA, which can significantly increase the drug development timeline and expenses. We may elect either on our own, or at the request of the FDA, to conduct further studies that are referred to as Phase 3B and 4 studies. Phase 3B studies are initiated and either completed or substantially completed while the BLA is under FDA review. These studies are conducted under an IND. Phase 4 studies, also referred to as post-marketing studies, are studies that are initiated and conducted after the FDA has approved a product for marketing. In addition, as discovery research, preclinical development, and clinical programs progress, opportunities to expand development of drug candidates into new disease indications can emerge. We may elect to add such new disease indications to our development efforts (with the approval of our collaborator for joint development programs), thereby extending the period during which we will be developing a product. For example, we, and our collaborators, where applicable,
continue to explore further development of the IL-1 Trap, VEGF Trap, and VEGF Trap-Eye in different disease indications.

There are numerous uncertainties associated with drug development, including uncertainties related to safety and efficacy data from each phase of drug development, uncertainties related to the enrollment and performance of clinical trials, changes in regulatory requirements, changes in the competitive landscape affecting a product candidate, and other risks and uncertainties described under “Risk Factors -- Risks Related to Development of our Product Candidates,” “--Regulatory and Litigation Risks”, and “--Risks Related to Commercialization of Products.” The lengthy process of seeking FDA approvals, and subsequent compliance with applicable statutes and regulations, require the expenditure of substantial resources. Any failure by us to obtain, or delay in obtaining, regulatory approvals could materially adversely affect our business. We cannot assure you
that we will obtain any approval required by the FDA on a timely basis, if at all.

Mr. Jim B. Rosenberg

Senior Assistant Chief Accountant

Securities and Exchange Commission

Page 4

We budget our research and development costs by expense category, rather than by project. We also prepare estimates of research and development costs for projects in clinical development, which include direct costs and allocations of certain costs such as indirect labor, non-cash stock-based employee compensation expense related to stock option awards, and manufacturing and other costs related to activities that benefit multiple projects. Our estimates of research and development costs for clinical development programs are shown below:

(In millions)

Year ended December 31,

Project Costs

2006

2005

Increase

(Decrease)

VEGF Trap – Oncology

$30.7

$27.8

$2.9

VEGF Trap- Eye

21.9

9.3

12.6

IL-1 Trap

29.6

57.2

(27.6)

Other research programs & unallocated costs

54.9

61.3

(6.4)

Total research and development expenses

$137.1

$155.6

($18.5)

For the reasons described above and due to the variability in the costs necessary to develop a product, the uncertainties related to future indications to be studied, the estimated cost and scope of the projects, and uncertainty as to our ultimate ability to obtain governmental approval for commercialization, accurate and meaningful estimates of the total cost to bring our product candidates to market are not available. Similarly, we are currently unable to reasonably estimate if our product candidates will generate product revenues and material net cash inflows. We plan to submit a BLA for our IL-1 Trap for the treatment of CAPS, a spectrum of rare genetic disorders, in the second quarter of 2007. We cannot predict whether or when the commercialization of the IL-1 Trap in CAPS will result in a material net cash inflow to the company.

Funding Requirements, page 44

2.

Please explain in disclosure-type format your basis for omitting estimated payments from the table of contractual obligations that appear reasonably likely to arise from your research and development agreements with sanofi-aventis and Bayer Healthcare LLC. Discuss how profitability will be measured, your expected timing for achieving profitability and payment of development expense reimbursements if the collaborations are profitable.

The Company advises the Staff that under our research and development agreement with sanofi-aventis, the Company will be obligated to reimburse sanofi-aventis for 50% of the development expenses incurred by both companies out of our share of any future profits generated by the collaboration. We will repay sanofi-aventis for these development expenses in accordance with a formula based on the amount of development expenses incurred under the research and

Mr. Jim B. Rosenberg

Senior Assistant Chief Accountant

Securities and Exchange Commission

Page 5

development agreement and our share of profits generated in a calendar quarter. We disclosed this obligation in the Annual Report on page 42 (see “Liquidity and Capital Resources -- Collaboration with the sanofi-aventis Group”) and on page 30 (see “Collaborations -- The sanofi-aventis Group”).

We are unable to estimate development costs over the term of the sanofi-aventis arrangement which would be subject to reimbursement. These reimbursements are contingent contractual obligations which are predicated on the collaboration becoming profitable. In addition, the Company will not be required to make payments to sanofi-aventis to satisfy this reimbursement obligation. Rather, the reimbursement will be deducted from payments the Company would have otherwise been entitled to receive from sanofi-aventis out of our share of the collaboration’s profits, assuming that profitability is achieved. If profitability is never achieved, we will have no obligation to reimburse sanofi-aventis.

The Company also advises the Staff that under our research and development agreement with Bayer HealthCare, agreed upon VEGF Trap-Eye development expenses incurred by both companies, beginning in 2007, under a global development plan will be shared, as described in the Annual Report (see page reference below). If the collaboration becomes profitable, the Company will be obligated to reimburse Bayer HealthCare for 50% of Bayer HealthCare’s share of the VEGF Trap-Eye development expenses out of our share of the collaboration profits. We disclosed this obligation in the Annual Report on page 43 (see “Liquidity and Capital Resources -- Collaboration with Bayer Healthcare”) and on page 31 (see “Collaborations -- Bayer Healthcare LLC”).

We are unable to estimate development costs over the term of the Bayer HealthCare arrangement which would be subject to reimbursement. These reimbursements are contingent contractual obligations which are predicated on the collaboration becoming profitable. In addition, the Company will not be required to make payments to Bayer HealthCare to satisfy this reimbursement obligation. Rather, the reimbursement will be deducted from payments the Company would have otherwise been entitled to receive from Bayer HealthCare out of our share of the collaboration’s profits, assuming that profitability is ever achieved. If profitability is never achieved, we will have no obligation to reimburse Bayer HealthCare.

The Company acknowledges the Staff’s comment. In future filings, we will expand our discussion under “Funding Requirements” to explain why the contingent contractual obligations for reimbursement of development expenses incurred by sanofi-aventis and Bayer HealthCare have been omitted from the table of contractual obligations. Our disclosure would be supplemented substantially as follows:

Mr. Jim B. Rosenberg

Senior Assistant Chief Accountant

Securities and Exchange Commission

Page 6

As described above under “Collaboration with Bayer Healthcare”, over the next several years we and Bayer Healthcare are sharing agreed-upon VEGF Trap-Eye development expenses.

In addition, as described above under “Collaboration with the sanofi-aventis Group” and “Collaboration with Bayer Healthcare”, if the applicable collaboration becomes profitable, we have contingent contractual obligations to reimburse sanofi-aventis and Bayer Healthcare for 50% of agreed-upon development expenses incurred by sanofi-aventis and Bayer Healthcare, respectively. Profitability under each collaboration will be measured by calculating net sales less agreed-upon expenses. These reimbursements will be deducted from our share of the collaboration profits and, for sanofi-aventis, royalties otherwise payable to us based on product sales in Japan, unless we agree to reimburse these expenses at a faster rate at our option. Given the uncertainties related to drug
development (including the development of the VEGF Trap-Oncology in collaboration with sanofi-aventis and the VEGF Trap-Eye in collaboration with Bayer Healthcare) such as the variability in the length of time necessary to develop a product candidate and the ultimate ability to obtain governmental approval for commercialization, we are currently unable to reliably estimate if our collaborations with sanofi-aventis and Bayer Healthcare will become profitable.

Critical Accounting Policies and Significant Judgments and Estimates

Revenue Recognition, page 46

3.

You do not appear to have discussed the variability implicit in critical accounting estimates associated with your revenue recognition of contract research and development and research progress payments. Your disclosure should provide investors with a fuller understanding of the uncertainties in applying critical accounting estimates and the likelihood that materially different amounts would be reported under different conditions or using different assumptions. It should include quantification of the related variability in operating results that you expect to be reasonably likely to occur. Please describe in disclosure-type format the expected uncertainties and variability implicit in critical accounting estimates associated with your revenue recognition of these payments, the effect that changes in such estimates have had on your financial statements for each period presented, and the
effect that reasonably likely changes in the key assumptions underlying these estimates may have on your financial statements in the future. Also, explain your basis for concluding that research and development activities other than clinical trial expenses do not involv