SEC Company Response from REGENERON PHARMACEUTICALS, INC. (REGN) (CIK 0000872589) (REGN) — Jul 27, 2009
REGENERON PHARMACEUTICALS, INC. (REGN) (CIK 0000872589)
Date: July 27, 2009 · CIK: 0000872589 · Accession: 0001206774-09-001434
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File numbers found in text: 000-19034
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CORRESP
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filename1.htm
Stuart Kolinski, Esq.
Phone
914 345 7498
Senior Vice President & General
Counsel
Fax
914 345 7721
Regeneron Pharmaceuticals, Inc.
www.regeneron.com
777 Old Saw Mill River Road
Tarrytown, NY 10591-6707
July 27, 2009
BY EDGAR
Mr. Jeffrey Riedler
Assistant Director
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, NE
Washington, D.C. 20549
RE:
Regeneron
Pharmaceuticals, Inc.
Form 10-K for
the fiscal year ended December 31, 2008
Filed February
26, 2009
Definitive Proxy
Statement on Schedule 14A
Filed April 24,
2009
File No.
000-19034
Dear Mr. Riedler:
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 July 15, 2009 (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 “Form
10-K”) and the above-referenced definitive proxy statement on Schedule 14A (the
“Proxy Statement”). For the convenience of the Staff, this letter restates in
bold each of the comments in the Comment Letter, and immediately thereafter sets
forth the Company's response. Capitalized terms used and not defined regarding
the Form 10-K or Proxy Statement have the meanings to such terms given in the
Form 10-K or Proxy Statement, as applicable. References to page numbers and
captions correspond to the page numbers and captions in the Form 10-K or the
Proxy Statement as indicated.
Form 10-K for the year ended
December 31, 2008
Item 1.
Business
Patents. Trademarks, and Trade Secrets, page
11
1.
Please expand your intellectual property
disclosure to identify your material patents and patent applications, discuss
the technology and product candidates dependent on these patents and disclose
their respective expiration dates. Where you have licensed a material patent
from another party, please identify the licensor, describe the terms of your
agreement, and ensure that the license agreement has been filed as an exhibit to
your filing. It may be helpful to provide your revised disclosure in chart form.
In our future Form 10-K filings, we will
expand our discussion of intellectual property in compliance with the Staff's
comment. Specifically, subject to updating to reflect changes in our
intellectual property rights after the date hereof, we propose that the
disclosure under the caption Patents, Trademarks and Trade Secrets will be
substantially as follows:
“Our success depends, in part, on our
ability to obtain patents, maintain trade secret protection, and operate without
infringing on the proprietary rights of third parties (see “Risk Factors –
We may be restricted in our development and/or
commercialization activities by, and could be subject to damage awards if we are
found to have infringed, third party patents or other proprietary
rights.”). Our policy is to file patent
applications to protect technology, inventions, and improvements that we
consider important to our business and operations. As of December 31, 2008, we
held an ownership interest in a total of approximately 150 issued patents in the
United States and over 670 issued patents in foreign countries with respect to
our products and technologies. In addition, we held an ownership interest in
hundreds of patent applications in the United States and foreign
countries.
Our patent portfolio includes granted
patents and pending patent applications covering our VelociSuite™ technologies,
including our VelocImmune® mouse platform which produces fully human monoclonal
antibodies. Our issued patents covering these technologies generally expire
between 2020 and 2030. However, we continue to file patent applications directed
to improvements to these technology platforms.
Our patent portfolio also includes issued
patents and pending applications relating to our marketed product, ARCALYST®,
and our product candidates in clinical development. These patents cover the
proteins and DNA encoding the proteins, manufacturing patents, method of use
patents, pharmaceutical compositions, as well as various methods of using the
products. For each of ARCALYST and our late-stage clinical candidates,
aflibercept (VEGF Trap) and the VEGF Trap-Eye, these patents generally expire
between 2020 and 2026. However, the projected patent terms may be subject to
extension based on potential patent term extensions in countries where such
extensions are available.
We also are the nonexclusive licensee of a
number of additional patents and patent applications. In July 2008 we entered
into an Amended and Restated Non-Exclusive License Agreement with Cellectis S.A.
pursuant to which we licensed certain patents and patent applications relating
to a process for the specific replacement of a copy of a gene in the receiver
genome by homologous recombination. Pursuant to this agreement, we agreed to pay
Cellectis a low, single-digit royalty based on any future revenue received by us
from any future licenses or sales of our VelociGene® or VelocImmune products or
services. No royalties are payable on any revenue from commercial sales of
antibodies from our VelocImmune technology. We also have non-exclusive license
agreements with Amgen and other organizations for patent rights related to
ARCALYST. In exchange for these licenses, we pay a mid-single digit royalty on
net sales of ARCALYST.
Patent law relating to the patentability
and scope of claims in the biotechnology field is evolving and our patent rights
are subject to this additional uncertainty. The degree of patent protection that
will be afforded to our products in the United States and other important
commercial markets is uncertain and is dependent upon the scope of protection
decided upon by the patent offices, courts and governments in these countries.
There is no certainty that our existing patents or others, if obtained, will
provide us protection from competition or provide commercial benefit.
Others may independently develop similar
products or processes to those developed by us, duplicate any of our products or
processes or, if patents are issued to us, design around any products and
processes covered by our patents. We expect to continue, when appropriate, to
file product and process applications with respect to our inventions. However,
we may not file any such applications or, if filed, the patents may not be
issued. Patents issued to or licensed by us may be infringed by the products or
processes of others.
Defense and enforcement of our
intellectual property rights is expensive and time consuming, even if the
outcome is favorable to us. It is possible that patents issued or licensed to us
will be successfully challenged, that a court may find that we are infringing
validly issued patents of third parties, or that we may have to alter or
discontinue the development of our products or pay licensing fees to take into
account patent rights of third parties.”
Item 15. Exhibits and Financial
Statement Schedules, page 58
2.
Please file your August 2008 agreement
with sanofi-aventis, in relation to their use of your VelociGene platform, as an
exhibit to your filing or identify the filing in which this agreement will be
filed as an exhibit. Please note that we will not be in a position to clear our
comment until this agreement has been filed.
The Company did not include its August
2008 agreement with sanofi-aventis as an exhibit to the Form 10-K because it
considers that agreement to be both made in the ordinary course
and not
material to the Company, and therefore not a required exhibit under Item 601(10)
of Regulation S-K. The ordinary course nature of this agreement is evidenced by
the fact that the Company has entered into similar agreements with a number of
other parties (e.g., Serono, the Karolinska Institute, the Gates Foundation, the
Spinal Muscle Atrophy (SMA) Foundation, etc.) whereby, as with the mouse
purchase agreement with sanofi-aventis, such parties pay specified amounts to
the Company for the Company to supply them with genetically modified mammalian
models of gene function and disease. Moreover, like these other agreements, the
VelociGene® agreement with sanofi-aventis is not material to the Company from a
financial or any other perspective. The Company is entitled to receive
approximately $4 million annually under the agreement, and the existence or
non-existence of this agreement does not affect the Company's rights or
obligations under its larger, worldwide antibody collaboration with
sanofi-aventis. In light of the foregoing, the Company believes that the
VelociGene® agreement with sanofi-aventis is not a required exhibit to the Form
10-K, and respectfully requests that the Staff reconsider this comment.
Definitive Proxy
Statement
Executive Compensation, page
21
Compensation Discussion and Analysis
3.
Please identify the “nationally recognized
surveys” that your Compensation Committee uses to benchmark compensation for
your NEOs.
The nationally recognized compensation
survey used by the Compensation Committee to benchmark 2008 compensation for the
Company's Named Officers is the Radford Global Life Sciences Survey. If the
Compensation Committee continues to use one or more nationally recognized
compensation surveys to benchmark compensation for the Company's Named Officers,
in future annual meeting proxy statements such compensation survey(s) will be
identified. Specifically, by reference to the Proxy Statement, the second
sentence of the last paragraph under the caption "Peer Group" (on page 22) would
be revised to read as follows:
"In addition, management and the
Compensation Committee reviewed compensation data for biotechnology companies
from the Radford Global Life Sciences Survey to benchmark total compensation
paid to our Named Officers."
Cash Bonus, page
23
4.
We note that your disclosure in relation
to the cash bonus for NEOs does not describe how the listed corporate
performance goals and individual contributions are assessed to determine the
“personal performance multiplier” and “company performance multiplier.” Please
provide us with draft disclosure for your 2009 proxy statement which provides
the following:
Disclosure of specific corporate
performance objectives and personal performance objectives used to calculate the
applicable multiplier(s) for each NEO; Identification of specific target figures
for each objective to the extent that multipliers are calculated based on the
achievement of quantified performance targets;
Discussion of how the level of achievement in relation to the
objectives is assessed to determine the respective “personal performance
multiplier” and “company performance multiplier;” and,
Confirmation that you
will discuss the level of achievement with respect to these objectives in your
2009 proxy statement.
The payment of annual cash bonuses to the
Company’s Named Officers with respect to the 2008 fiscal year was based entirely
upon the discretion of the Company’s Compensation Committee. As stated on page
23 of the Proxy Statement “Although each Named Officer is eligible to receive an
annual bonus, we historically have had no formal bonus plan and the granting of
any bonus to a Named Officer is entirely at the discretion of the Compensation
Committee.” Specifically, the company performance multiplier was determined
based on the Compensation Committee’s subjective assessment of the Company’s
performance with respect to the general corporate goals described on pages 23
and 24 of the Proxy Statement. Similarly, the determination of the personal
performance multiplier was based upon a subjective assessment by the
Compensation Committee of the particular Named Officer’s performance. There
were, however, no specific target achievement levels, and no specific formulas
or metrics by which to measure performance, established with respect to these
company and personal goals. Thus, the determination of the company and personal
performance multipliers were made by the Compensation Committee in its
discretion and not by the application of any pre-established formulas to
specific performance targets. The Compensation Committee is continuing in its
2009 fiscal year the practice of determining annual bonus payments to its Named
Officers on a discretionary basis. Although the disclosure in the Proxy
Statement does describe the discretionary nature of these annual bonuses, the
Company will, in its 2009 proxy statement, provide additional disclosure to
reinforce this fact. Specifically, the Company expects to include in its 2009
proxy statement a sentence substantially as follows:
“Both the personal performance multiplier
and the company performance multiplier were determined by the Compensation
Committee in its discretion based on the Committee’s subjective assessment of
the Company’s performance of the general corporate goals described on pages 23
and 24 and the Named Officers’ performance during the year.”
Performance Based Vesting Stock
Options, page 25
5.
We note that the vesting of your
performance based vesting stock options is determined based on points earned for
the achievement of “product candidate development milestones.” Please provide
additional disclosure about how these stock options vest under your “point scale
system.” In particular, please provide us with draft disclosure for your 2009
proxy statement which provides the following:
A discussion of how many points were
earned by NEOs based upon the achievement of development milestones in 2008;
A discussion of the specific points attributed to each respective
achievement; and,
The number of options that vested as a result of the points
earned.
The performance based vesting stock
options described in the Proxy Statement were granted very late in the 2008
fiscal year. As stated on page 24 of the Proxy Statement, “stock option awards
were granted to our Named Officers and other eligible employees on December 17,
2008.” As described below, none of the performance based vesting stock options
vested in 2008.
As disclosed in the Proxy Statement,
points may be earned with respect to the vesting of the stock options upon the
achievement of product candidate development milestones "between the grant date
and December 31, 2011 . . ." However, the Company wishes to emphasize that (as
is also disclosed in the Proxy Statement), the performance based vesting stock
options described in the Proxy Statement are generally not eligible to vest
until December 31, 2011, and only if the recipient remains continuously employed
through that date, irrespective of the number of points earned through that
date. Accordingly, the Company believes that the disclosure requested by the
Staff with respect to the performance based vesting stock options would be
material and appropriate in the proxy statement covering the year in which such
options actually vest, if such vesting were to occur. In the case of the
performance based vesting stock options described in the Proxy Statement, this
disclosure would be included in the 2012 annual meeting proxy statement, as the
options will generally only be eligible to vest on December 31, 2011 (assuming
no accelerated vesting in the interim due to a change in control or exercise of
Compensation Committee discretion). Only on the vesting eligibility date for any
grant of performance based vesting options will it be possible to know the
extent to which such option grant has vested.
In this regard, the Company also notes
that it expects that similar grants of performance based vesting stock options
will be made in the future on an annual basis. As a result, the Company expects
that in the future there will be multiple performance based v