SEC Company Response from ENZON PHARMACEUTICALS, INC. (ENZN) (CIK 0000727510) (VISK) — Sep 20, 2012
ENZON PHARMACEUTICALS, INC. (ENZN) (CIK 0000727510)
Date: Sept. 20, 2012 · CIK: 0000727510 · Accession: 0001144204-12-052206
AI Filing Summary & Sentiment
Reasoning
File numbers found in text: 000-12957
Referenced dates: September 7, 2012
Letter
VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance Form 10-K for the Fiscal Year Ended December 31, 2011 Filed March 12, 2012 File No. 000-12957
Re: Enzon Pharmaceuticals, Inc.
Dear Mr. Rosenberg:
This letter sets forth the responses of Enzon Pharmaceuticals, Inc. (the “Company”) to the additional comments raised in the letter dated September 7, 2012 (the “Second Comment Letter”) from the staff (the “Staff”) of the United States Securities and Exchange Commission (the “Commission”) related to the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2011 filed on March 12, 2012 (the “2011 Form 10-K”) and the Company’s August 13, 2012 response to the Staff’s July 30, 2012 letter. Set forth below are the Company’s responses to the Staff’s comments as set forth in the Second Comment Letter. To facilitate your review, the Staff’s comments set forth in the Second Comment Letter are reprinted below in italics, numbered to correspond with the paragraph numbers assigned in the Second Comment Letter, and are followed by the corresponding response from the Company.
Patents and Intellectual Property Rights, page 15
1. We note your response to the first part of our prior comment 2. However, we deem expiration dates of material patents to be material information to investors. Please revise your disclosure to provide the expiration dates relating to your material patents covering improved methods of attaching PEG to therapeutic compounds and PEG-modified compounds that the company has identified or created. Alternatively, please provide a supplemental analysis detailing why they are not material to your business.
Mr. Jim B. Rosenberg, Senior Assistant Chief Accountant
United States Securities and Exchange Commission
September 20, 2012
Page 2
Response:
With respect to the Staff’s request that the Company provide the expiration dates of any material patents covering improved methods of attaching PEG to therapeutic compounds and PEG-modified compounds that the company has identified or created, the Company proposes to include disclosure to the following effect under “Item 1. “Business – Patents and Intellectual Property Rights” in its next Annual Report on Form 10-K:
“The patents related to PEGINTRON (peginterferon alfa-2b) are expected to expire in 2013 and 2015 in the U.S. and internationally in 2018 (including any patent term extensions).”
Management’s Discussion and Analysis of Financial Condition and Results of Operations
Research and Development Expenses- Pipeline, page 45
2. We acknowledge your response to our prior comment 3. Your current disclosure of research and development expenses separately for pipeline and specialty and contracted services accompanied by discussion of variations in program expenses period over period lacks context without the amounts incurred for each program under these two categories. As you internally evaluate research and development costs on a program-by-program basis and in order to provide more insight into how you manage your R&D function, please provide proposed disclosure to be presented in future periodic reports of the breakdown of your R&D expenditures for the periods presented, consistent with your management of these activities (i.e. by program). In this disclosure indicate the costs you track by program and those you do not and explain how you use this information to manage your activities. Alternatively, provide other quantitative or qualitative disclosure that indicates the amount of your resources being used on each of the five projects that are described in this section.
Response:
With respect to the Staff’s request that the Company provide proposed disclosure to be presented in future periodic reports of the breakdown of R&D expenditures for the periods presented consistent with our management of these activities (i.e. by program) indicating the costs the Company tracks by program and those the Company does not, the Company proposes to include disclosure to the following effect under “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations – Research and Development Expenses – Pipeline” in its next Annual Report on Form 10-K and on an annual basis thereafter:
Mr. Jim B. Rosenberg, Senior Assistant Chief Accountant
United States Securities and Exchange Commission
September 20, 2012
Page 3
“Research and development - pipeline expenses consist primarily of contractor fees principally related to clinical projects; costs related to research and development collaborations or licenses; research and drug supplies for preclinical and clinical activities; personnel costs including salaries, benefits and stock-based compensation; and facilities-related costs including rent, real estate taxes, utilities, insurance and depreciation. Program costs are those research and development costs which are directly related to specific programs and are tracked and managed at the individual program level. Other research and development costs are those costs incurred related to the Company’s on-going research and development activities, such as some personnel and facilities-related expenses, which are not allocated to specific programs given their general nature.
The following table summarizes our major research and development - pipeline costs by program incurred for the years ended December 31, 2012, 2011 and 2010 and the current phases of development (millions of dollars):
For the year ended
December 31,
Current Phase of
Development
Program costs:
PEG-SN38 $ $ $ Phases I and II
HIF-1a antagonist
Phase I
Survivin antagonist
Phase I
Androgen Receptor antagonist
Phase I
Other program costs
Research/Preclinical
Other research and development costs
Total research and development - pipeline costs $ $ $
****
In responding to the Staff’s comments, the Company acknowledges the following:
· the Company is responsible for the adequacy and accuracy of the disclosure in the filing;
· Staff comments or changes to disclosure in response to Staff comments do not foreclose the Commission from taking any action with respect to the filing; 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.
Mr. Jim B. Rosenberg, Senior Assistant Chief Accountant
United States Securities and Exchange Commission
September 20, 2012
Page 4
Should you have any questions or comments relating to this letter, kindly contact the undersigned at (732) 980-4500.
Very truly yours,
/s/ George W. Hebard III
Show Raw Text
CORRESP
1
filename1.htm
September 20, 2012
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F. Street, N.E.
Washington, D.C. 20549
Attn: Mr. Jim B. Rosenberg, Senior Assistant Chief Accountant
Re: Enzon Pharmaceuticals, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2011
Filed March 12, 2012
File No. 000-12957
Dear Mr. Rosenberg:
This letter sets forth
the responses of Enzon Pharmaceuticals, Inc. (the “Company”) to the additional comments raised in the letter
dated September 7, 2012 (the “Second Comment Letter”) from the staff (the “Staff”) of the
United States Securities and Exchange Commission (the “Commission”) related to the Company’s Annual Report
on Form 10-K for the fiscal year ended December 31, 2011 filed on March 12, 2012 (the “2011 Form 10-K”) and
the Company’s August 13, 2012 response to the Staff’s July 30, 2012 letter. Set forth below are the Company’s
responses to the Staff’s comments as set forth in the Second Comment Letter. To facilitate your review, the Staff’s
comments set forth in the Second Comment Letter are reprinted below in italics, numbered to correspond with the paragraph numbers
assigned in the Second Comment Letter, and are followed by the corresponding response from the Company.
Patents and Intellectual Property Rights, page 15
1. We note your response to the first part of our prior comment 2. However, we deem expiration
dates of material patents to be material information to investors. Please revise your disclosure to provide the expiration dates
relating to your material patents covering improved methods of attaching PEG to therapeutic compounds and PEG-modified compounds
that the company has identified or created. Alternatively, please provide a supplemental analysis detailing why they are not material
to your business.
Mr. Jim B. Rosenberg, Senior Assistant Chief Accountant
United States Securities and Exchange Commission
September 20, 2012
Page 2
Response:
With respect to the Staff’s
request that the Company provide the expiration dates of any material patents covering improved methods of attaching PEG to therapeutic
compounds and PEG-modified compounds that the company has identified or created, the Company proposes to include disclosure to
the following effect under “Item 1. “Business – Patents and Intellectual Property Rights” in its next Annual
Report on Form 10-K:
“The patents related to
PEGINTRON (peginterferon alfa-2b) are expected to expire in 2013 and 2015 in the U.S. and internationally in 2018 (including any
patent term extensions).”
Management’s Discussion and Analysis of Financial Condition
and Results of Operations
Research and Development Expenses- Pipeline, page 45
2. We acknowledge your response to our prior comment 3. Your current disclosure of research and
development expenses separately for pipeline and specialty and contracted services accompanied by discussion of variations in program
expenses period over period lacks context without the amounts incurred for each program under these two categories. As you internally
evaluate research and development costs on a program-by-program basis and in order to provide more insight into how you manage
your R&D function, please provide proposed disclosure to be presented in future periodic reports of the breakdown of your R&D
expenditures for the periods presented, consistent with your management of these activities (i.e. by program). In this disclosure
indicate the costs you track by program and those you do not and explain how you use this information to manage your activities.
Alternatively, provide other quantitative or qualitative disclosure that indicates the amount of your resources being used on each
of the five projects that are described in this section.
Response:
With respect to the Staff’s
request that the Company provide proposed disclosure to be presented in future periodic reports of the breakdown of R&D expenditures
for the periods presented consistent with our management of these activities (i.e. by program) indicating the costs the Company
tracks by program and those the Company does not, the Company proposes to include disclosure to the following effect under “Item
7. Management’s Discussion and Analysis of Financial Condition and Results of Operations – Research and Development
Expenses – Pipeline” in its next Annual Report on Form 10-K and on an annual basis thereafter:
Mr. Jim B. Rosenberg, Senior Assistant Chief Accountant
United States Securities and Exchange Commission
September 20, 2012
Page 3
“Research and development
- pipeline expenses consist primarily of contractor fees principally related to clinical projects; costs related to research and
development collaborations or licenses; research and drug supplies for preclinical and clinical activities; personnel costs including
salaries, benefits and stock-based compensation; and facilities-related costs including rent, real estate taxes, utilities, insurance
and depreciation. Program costs are those research and development costs which are directly related to specific programs and are
tracked and managed at the individual program level. Other research and development costs are those costs incurred related to the
Company’s on-going research and development activities, such as some personnel and facilities-related expenses, which are
not allocated to specific programs given their general nature.
The following table summarizes
our major research and development - pipeline costs by program incurred for the years ended December 31, 2012, 2011 and 2010 and
the current phases of development (millions of dollars):
For the year ended
December 31,
Current Phase of
2012
2011
2010
Development
Program costs:
PEG-SN38
$
$
$
Phases I and II
HIF-1a antagonist
Phase I
Survivin antagonist
Phase I
Androgen Receptor antagonist
Phase I
Other program costs
Research/Preclinical
Other research and development costs
Total research and development - pipeline costs
$
$
$
****
In responding to the Staff’s comments,
the Company acknowledges the following:
· the Company is responsible for the adequacy and accuracy of the disclosure in the filing;
· Staff comments or changes to disclosure in response to Staff comments do not foreclose the Commission from taking any action
with respect to the filing; 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.
Mr. Jim B. Rosenberg, Senior Assistant Chief Accountant
United States Securities and Exchange Commission
September 20, 2012
Page 4
Should you have any questions
or comments relating to this letter, kindly contact the undersigned at (732) 980-4500.
Very truly yours,
/s/ George W. Hebard III
George W. Hebard III
cc: Sasha Parikh, Staff Accountant
Mark Brunhofer, Senior Staff Accountant
Everson Ladson, Staff Attorney
Jeffrey Riedler, Assistant Director
Charles Conover, Enzon Pharmaceuticals, Inc.
Timothy G. Daly, Enzon Pharmaceuticals, Inc.
Andrew Rackear, Enzon Pharmaceuticals, Inc.
Scott Kain, Enzon Pharmaceuticals, Inc.
Lawrence Goodman, Esq., Curtis, Mallet-Prevost, Colt
& Mosle LLP