SEC Company Response from NEKTAR THERAPEUTICS (NKTR) (CIK 0000906709) (NKTR) — Jan 26, 2009
NEKTAR THERAPEUTICS (NKTR) (CIK 0000906709)
Date: Jan. 26, 2009 · CIK: 0000906709 · Accession: 0001144204-09-003317
AI Filing Summary & Sentiment
File numbers found in text: 000-24006
Referenced dates: December 10, 2008
Show Raw Text
CORRESP
1
filename1.htm
Nektar
Therapeutics
201
Industrial Road
San
Carlos, California 94070
Sender
Contact Information
P: (650)
620-5990
F: (650)
620-5360
January
26, 2009
VIA ELECTRONIC
TRANSMISSION
Securities
and Exchange Commission
Division
of Corporate Finance
Washington,
D.C. 20549
Attention: Nandini
Acharya, Esq.
Re:
Nektar
Therapeutics — Form 10-K for the Year Ended December 31, 2007 (File
No. 000-24006)
Dear Ms.
Acharya:
We are in
receipt of the letter dated December 10, 2008 (the “Comment Letter”), including
comments from the staff (the “Staff”) of the Securities and
Exchange Commission (the “Commission”) to the Form 10-K
for the year ended December 31, 2007 (File No. 000-24006) filed by Nektar
Therapeutics, a Delaware corporation (the “Registrant”), on February 29,
2008 (the “Form
10-K”). Set forth below are the Registrant’s responses to the
Staff’s comments. The numbers associated with the headings and
responses set forth below correspond to the numbered comments in the letter from
the Staff.
We
request, pursuant to 17 C.F.R. §200.83, that you accord confidential treatment
to the portions of this letter that are redacted and marked “[***]” in the
EDGAR-filed copy of this response letter and not disclose such provisions to any
person who is not an employee of the Commission unless otherwise required to do
so by law. Confidential treatment is requested to protect
confidential financial or commercial information the publication of which would
result in competitive disadvantages. Along with its redacted
EDGAR-filed copy, the Registrant is concurrently delivering an unredacted hard
copy of its response to the Commission.
Item 1. Business,
pages 6-7
Approved Products and
Clinical Pipeline
1.
We note that the agreements
related to several of the partnered product candidates listed on your
chart on pages 6-7 are not described in your Business section or
filed as exhibits to your Form 10-K. Please expand your
disclosure in the Business section to provide a description of each of the
following agreements, including the material terms of each agreement, the
aggregate potential milestone payments, the aggregate royalty and
milestone amounts received or paid to date and the term and termination
provisions. If any of the agreements terminate upon the
last-to-expire relevant patent, please disclose the year of expiration of
such patent. Item 601(b)(10) of Regulation S-K
requires you to include material contracts as exhibits. Please
file each agreement as an exhibit to the Form 10-K or provide us with
a comprehensive analysis supporting your determination that these
agreements are not material to your
business:
·
Agreement with Solvay
Pharmaceuticals related to pulmonary
dronabinol;
·
Agreement with Amgen, Inc.
related to Neulasta®;
·
Agreement with Hoffman-La
Roche, Ltd. related to
PEGASYS®;
·
Agreement with Pfizer, Inc.
related to Somavert®;
·
Agreement with Schering-Plough
Corporation related to
PEG-INTRON®;
·
Agreement with OSI
Pharmaceuticals (formerly Eyetech) related to
Macugen®;
·
Agreement with Affymax, Inc.
related to Hematide™; and
·
Agreement with UCB Pharma
related to CDP 791.
Response:
The
Registrant respectfully submits that the contracts entered in relation to
partnered product candidates are not material to the business of the Registrant
and are not required to be filed with the Form 10-K. The Registrant
further respectfully requests that the Registrant not be required to amend the
Form 10-K to expand the disclosure in the Business section. As
discussed below, given the significant events affecting the Registrant starting
in late 2007 and the substantial changes in the Registrant’s business focus in
2008, and since the contracts related to partnered product candidates were each
such as ordinarily accompany the kind of business conducted by the Registrant
and on which the Registrant was not substantially dependent, the Registrant
respectfully submits that an amendment attempting to characterize such contracts
in the context of the Registrant’s business as it existed in 2007 would not be
useful, and could be confusing, to current investors.
Historically,
the Registrant depended on revenue from its pulmonary business, in particular
contract research and manufacturing revenue from Pfizer, Inc. related to
Exubera®, an inhaled powder human insulin drug-device combination
product. Revenue from Pfizer represented 64% and 69% of the
Registrant’s total revenue for the years 2006 and 2007,
respectively. In October 2007, Pfizer announced that it was exiting
the Exubera business and, in November 2007, the Registrant entered a termination
agreement and mutual release with Pfizer (the “Pfizer
Termination”). In the Form 10-K, the Registrant disclosed that
it was seeking a new marketing and development partner for Exubera or the
related next generation inhaled insulin development program (NGI) and that
Pfizer had agreed to maintain certain manufacturing capabilities for an interim
period. On April 9, 2008, the Registrant announced that it had
ceased all negotiations with potential partners for Exubera and NGI as a result
of new data analysis from ongoing clinical trials conducted by Pfizer and would
cease all spending associated with the inhaled insulin programs.
2
On
October 20, 2008, the Registrant and Aerogen, Inc., a Delaware corporation and a
wholly-owned subsidiary of Nektar (“Aerogen”), entered into an
Asset Purchase Agreement (the “Asset Purchase Agreement”)
with Novartis Pharmaceuticals Corporation, a Delaware corporation, and Novartis
Pharma AG, a Swiss corporation (together with Novartis Pharmaceuticals, “Novartis”), to transfer to
Novartis certain of the assets related to the Registrant’s pulmonary business,
associated technology and intellectual property for a purchase price of $115
million in cash (the “Pulmonary
Asset Sale”). The Registrant completed the Pulmonary Asset
Sale effective as of 11:59 p.m. on December 31, 2008.
The
Registrant’s business has changed fundamentally since the Pfizer
Termination. The Registrant’s termination of its agreements with
Pfizer and the substantial revenue those agreements provided, the cessation of
spending associated with developing and maintaining the inhaled insulin programs
and the completion of the Pulmonary Asset Sale has altered the Registrant’s
business from one weighted towards investment in pulmonary technologies and
deriving a significant portion of total revenue from Pfizer to a business
focused on the PEGylation technology drug development platform that is designed
to enhance performance of a variety of drug classes and the clinical development
of product candidates based on this platform. As a result of the
Pfizer Termination and the Pulmonary Asset Sale, the Registrant is no longer
party to some of the agreements listed in the Comment Letter related to the
pulmonary business. Though the Registrant remains party to the
partnership agreements related to the PEGylation business, the contracts entered
in relation to such partnerships (i) are such as ordinarily accompany the kind
of business conducted by the Registrant and (ii) are not contracts (a) with
related parties, (b) upon which the Registrant’s business is or has been
substantially dependent, (c) calling for the acquisition or sale of any
property, plant or equipment for a consideration exceeding 15% of such fixed
assets of the Registrant on a consolidated basis or (d) that constitute material
leases. (See Item 601 under Regulation S-K.) In relation
to (b), the discussions that follow of each contract listed in Question 1
outline the percentage of total revenue related to each such contract since
2005. (Please note that any revenue amounts or percentages for 2008
included in this response to the Comment Letter are estimates and are subject to
adjustment in relation to the Registrant’s year-end financial
closing. The Registrant does not expect any adjustments related to
the year-end financial closing to materially alter the revenue amounts and
percentages in this response to the Comment Letter.)
The
Registrant will expand the disclosure in its Form 10-K for the year ended
December 31, 2008, to describe certain of its partnerships that it believes may
facilitate an understanding of its current business, though the Registrant
respectfully submits that such partnerships are not individually material to the
business of the Registrant. Below please find, in addition to
discussions of revenue related to each contract listed in Question 1, potential
disclosure related to each such contract, which the Registrant may include in
its Form 10-K for the year ended December 31, 2008.
In
relation to the Staff’s request that the Registrant include aggregate potential
milestone payments and the aggregate royalty and milestone amounts received or
paid to date, the Registrant respectfully requests that it not be required to
include such information. The Registrant respectfully submits that
disclosure of such payments and amounts is not required under Regulation S-K or
any other applicable rules or regulations because the Registrant does not
believe, as explained above, that any of the underlying partnerships is material
to the business of the Registrant and the Registrant’s business is not dependent
on revenue from any such payments or amounts. In addition, since
milestone and royalty payments are contingent on a number of factors, such as
clinical, regulatory and market success, which are subject to a number of
significant risks and uncertainties and are not typically in the control of
Registrant, the disclosure of specific milestone and royalty payments, when they
are only potential payments and might never be paid to the Registrant, could be
misleading. The specificity of such information could undermine the
Registrant’s best efforts to explain their contingency and create a false
confidence in the likelihood of receipt of such payments. Moreover,
the disclosure of such financial and commercial information would not be
customary and would result in competitive disadvantages and the release of
confidential information of the Registrant and its partners. Such
disclosure would compromise the Registrant’s position in negotiations with
future partners and would weaken the Registrant’s ability to command improved
economic terms.
3
In
relation to the Staff’s request that the Registrant disclose the year of
expiration of any patents that relate to a termination provision upon the
last-to-expire relevant patent, the Registrant respectfully requests that it not
be required to include such information. The expiration year of the
last-to-expire relevant patent under a contract can be difficult to determine
since patents are subject to various contingencies (as noted in relation to
enforceability, validity, scope and length of patent coverage in the section in
the Form 10-K titled “Patents and Proprietary Rights”) and the patent claims
that fall under a contract may change. Since the expiration year of
the last-to-expire relevant patent can change and disclosure of a fixed year
could be misleading, the Registrant respectfully requests that relevant contract
descriptions note that the contract terminates upon the last-to-expire relevant
patent and, in the future, the Registrant will consider disclosing a specific
year as such expirations approach.
(a)
Agreement with Solvay
Pharmaceuticals related to pulmonary
dronabinol
(i) Agreement Terminated as
of September 19, 2008
In
February 2002, the Registrant entered into a research and collaboration
agreement with Unimed Pharmaceuticals, Inc., a wholly owned subsidiary of Solvay
Pharmaceuticals, Inc., to develop a formulation of dronabinol (synthetic
delta-9-tetrahydrocannabinol) to be delivered using a metered dose inhaler as a
potential new migraine headache treatment. Under the terms of the
agreement, the Registrant was entitled to receive research and development
funding, milestone payments based on clinical progress and royalty payments on
product sales and manufacturing revenue if the product was
commercialized. On March 19, 2008, Solvay gave the Registrant notice
of termination and, pursuant to its terms, the agreement was terminated as of
September 19, 2008.
(ii) Agreement Made in the
Ordinary Course and Not Material to the Business
[***]. The
Registrant respectfully submits that, as a routine collaboration agreement made
in the ordinary course of its business from which the Registrant did not derive
a significant percentage of total revenue and on which the Registrant’s business
was not substantially dependent, the agreement was not material to the business
of the Registrant and is not required to be filed with the Form
10-K.
4
(b)
Agreement with Amgen,
Inc. related to Neulasta®
(i) Draft Disclosure for
Form 10-K for the Year Ended December 31, 2008
In July
1995, we entered into a supply and license agreement with Amgen, Inc., pursuant
to which we license our proprietary PEGylation technology to be used in the
development and manufacture of Neulasta®. Neulasta selectively
stimulates the production of neutrophils that are depleted by cytotoxic
chemotherapy, a condition called neutropenia that makes it more difficult for
the body to fight infections. We manufacture and supply our
proprietary PEGylation reagent for Amgen on a fixed price basis. The
term of the agreement is for a fixed duration with a limited number of renewal
options. We currently estimate that the last renewal term will expire
in 2010.
(ii) Agreement Made in the
Ordinary Course and Not Material to the Business
[***]. The
Registrant respectfully submits that, as a routine collaboration agreement made
in the ordinary course of its business from which the Registrant does not derive
a significant percentage of total revenue and on which the Registrant’s business
is not substantially dependent, the agreement is not material to the business of
the Registrant and is not required to be filed with the Form 10-K.
(c)
Agreement with
Hoffman-La Roche, Ltd. related to
PEGASYS®
(i) Draft Disclosure for
Form 10-K for the Year Ended December 31, 2008
In
February 1997, we entered into a license, manufacturing and supply agreement
with F. Hoffman La Roche Ltd. and Hoffman-La Roche, Inc. (Roche), under which we
granted Roche a worldwide, exclusive license to use certain PEGylation reagents
to manufacture and commercialize a certain class of products, of which Pegasys®
is the only product currently commercialized. Pegasys is approved in
the U.S., E.U. and other countries for the treatment of Hepatitis C and is
designed to help the patient’s immune system fight the Hepatitis C
virus. We currently manufacture our proprietary PEGylation reagent
for Roche on a price per gram basis. Roche has an option for a
license extension related to the agreement. The agreement expires on
the later of January 10, 2015 or the expiration of our last relevant patent
containing a valid claim, which we currently estimate to extend beyond
2015.
(ii) Agreement Made in the
Ordinary Course and Not Material to