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NEKTAR THERAPEUTICS
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1 company response(s)
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NEKTAR THERAPEUTICS
Response Received
1 company response(s)
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SEC wrote to company
2024-05-31
NEKTAR THERAPEUTICS
Summary
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NEKTAR THERAPEUTICS
Awaiting Response
0 company response(s)
High
SEC wrote to company
2021-12-13
NEKTAR THERAPEUTICS
Summary
UPLOAD · 2021-12-13
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NEKTAR THERAPEUTICS
Response Received
10 company response(s)
High - file number match
SEC wrote to company
2008-12-10
NEKTAR THERAPEUTICS
Summary
UPLOAD · 2008-12-10
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Company responded
2008-12-18
NEKTAR THERAPEUTICS
References: December 10, 2008
Summary
CORRESP · 2008-12-18
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Company responded
2009-01-14
NEKTAR THERAPEUTICS
References: December 10, 2008
Summary
CORRESP · 2009-01-14
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Company responded
2009-01-26
NEKTAR THERAPEUTICS
References: December 10, 2008
Summary
CORRESP · 2009-01-26
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Company responded
2009-02-19
NEKTAR THERAPEUTICS
References: December 10, 2008 | February 13, 2009
Summary
CORRESP · 2009-02-19
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Company responded
2011-08-11
NEKTAR THERAPEUTICS
References: July 28, 2011
Summary
CORRESP · 2011-08-11
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Company responded
2017-11-15
NEKTAR THERAPEUTICS
Summary
CORRESP · 2017-11-15
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Company responded
2017-11-20
NEKTAR THERAPEUTICS
Summary
CORRESP · 2017-11-20
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Company responded
2017-12-27
NEKTAR THERAPEUTICS
Summary
CORRESP · 2017-12-27
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Company responded
2018-12-07
NEKTAR THERAPEUTICS
References: November 19, 2018
Summary
CORRESP · 2018-12-07
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Company responded
2021-11-09
NEKTAR THERAPEUTICS
References: October 26, 2021
Summary
CORRESP · 2021-11-09
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NEKTAR THERAPEUTICS
Awaiting Response
0 company response(s)
High
SEC wrote to company
2021-10-26
NEKTAR THERAPEUTICS
Summary
UPLOAD · 2021-10-26
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NEKTAR THERAPEUTICS
Awaiting Response
0 company response(s)
High
SEC wrote to company
2019-02-08
NEKTAR THERAPEUTICS
Summary
UPLOAD · 2019-02-08
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NEKTAR THERAPEUTICS
Awaiting Response
0 company response(s)
High
SEC wrote to company
2018-11-19
NEKTAR THERAPEUTICS
Summary
UPLOAD · 2018-11-19
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NEKTAR THERAPEUTICS
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2018-01-16
NEKTAR THERAPEUTICS
Summary
UPLOAD · 2018-01-16
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NEKTAR THERAPEUTICS
Awaiting Response
0 company response(s)
High
SEC wrote to company
2017-12-14
NEKTAR THERAPEUTICS
Summary
UPLOAD · 2017-12-14
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NEKTAR THERAPEUTICS
Awaiting Response
0 company response(s)
High
SEC wrote to company
2017-11-01
NEKTAR THERAPEUTICS
Summary
UPLOAD · 2017-11-01
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NEKTAR THERAPEUTICS
Awaiting Response
0 company response(s)
High
SEC wrote to company
2011-08-26
NEKTAR THERAPEUTICS
Summary
UPLOAD · 2011-08-26
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NEKTAR THERAPEUTICS
Awaiting Response
0 company response(s)
High
SEC wrote to company
2011-07-28
NEKTAR THERAPEUTICS
Summary
UPLOAD · 2011-07-28
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NEKTAR THERAPEUTICS
Awaiting Response
0 company response(s)
High
SEC wrote to company
2009-02-23
NEKTAR THERAPEUTICS
Summary
UPLOAD · 2009-02-23
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NEKTAR THERAPEUTICS
Awaiting Response
0 company response(s)
High
SEC wrote to company
2009-02-13
NEKTAR THERAPEUTICS
References: December 10,
2008
Summary
UPLOAD · 2009-02-13
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-03-28 | Company Response | NEKTAR THERAPEUTICS | DE | N/A | Read Filing View |
| 2025-03-20 | SEC Comment Letter | NEKTAR THERAPEUTICS | DE | 377-07788 | Read Filing View |
| 2024-06-03 | Company Response | NEKTAR THERAPEUTICS | DE | N/A | Read Filing View |
| 2024-05-31 | SEC Comment Letter | NEKTAR THERAPEUTICS | DE | 333-279760 | Read Filing View |
| 2021-12-13 | SEC Comment Letter | NEKTAR THERAPEUTICS | DE | N/A | Read Filing View |
| 2021-11-09 | Company Response | NEKTAR THERAPEUTICS | DE | N/A | Read Filing View |
| 2021-10-26 | SEC Comment Letter | NEKTAR THERAPEUTICS | DE | N/A | Read Filing View |
| 2019-02-08 | SEC Comment Letter | NEKTAR THERAPEUTICS | DE | N/A | Read Filing View |
| 2018-12-07 | Company Response | NEKTAR THERAPEUTICS | DE | N/A | Read Filing View |
| 2018-11-19 | SEC Comment Letter | NEKTAR THERAPEUTICS | DE | N/A | Read Filing View |
| 2018-01-16 | SEC Comment Letter | NEKTAR THERAPEUTICS | DE | N/A | Read Filing View |
| 2017-12-27 | Company Response | NEKTAR THERAPEUTICS | DE | N/A | Read Filing View |
| 2017-12-14 | SEC Comment Letter | NEKTAR THERAPEUTICS | DE | N/A | Read Filing View |
| 2017-11-20 | Company Response | NEKTAR THERAPEUTICS | DE | N/A | Read Filing View |
| 2017-11-15 | Company Response | NEKTAR THERAPEUTICS | DE | N/A | Read Filing View |
| 2017-11-01 | SEC Comment Letter | NEKTAR THERAPEUTICS | DE | N/A | Read Filing View |
| 2011-08-26 | SEC Comment Letter | NEKTAR THERAPEUTICS | DE | N/A | Read Filing View |
| 2011-08-11 | Company Response | NEKTAR THERAPEUTICS | DE | N/A | Read Filing View |
| 2011-07-28 | SEC Comment Letter | NEKTAR THERAPEUTICS | DE | N/A | Read Filing View |
| 2009-02-23 | SEC Comment Letter | NEKTAR THERAPEUTICS | DE | N/A | Read Filing View |
| 2009-02-19 | Company Response | NEKTAR THERAPEUTICS | DE | N/A | Read Filing View |
| 2009-02-13 | SEC Comment Letter | NEKTAR THERAPEUTICS | DE | N/A | Read Filing View |
| 2009-01-26 | Company Response | NEKTAR THERAPEUTICS | DE | N/A | Read Filing View |
| 2009-01-14 | Company Response | NEKTAR THERAPEUTICS | DE | N/A | Read Filing View |
| 2008-12-18 | Company Response | NEKTAR THERAPEUTICS | DE | N/A | Read Filing View |
| 2008-12-10 | SEC Comment Letter | NEKTAR THERAPEUTICS | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-03-20 | SEC Comment Letter | NEKTAR THERAPEUTICS | DE | 377-07788 | Read Filing View |
| 2024-05-31 | SEC Comment Letter | NEKTAR THERAPEUTICS | DE | 333-279760 | Read Filing View |
| 2021-12-13 | SEC Comment Letter | NEKTAR THERAPEUTICS | DE | N/A | Read Filing View |
| 2021-10-26 | SEC Comment Letter | NEKTAR THERAPEUTICS | DE | N/A | Read Filing View |
| 2019-02-08 | SEC Comment Letter | NEKTAR THERAPEUTICS | DE | N/A | Read Filing View |
| 2018-11-19 | SEC Comment Letter | NEKTAR THERAPEUTICS | DE | N/A | Read Filing View |
| 2018-01-16 | SEC Comment Letter | NEKTAR THERAPEUTICS | DE | N/A | Read Filing View |
| 2017-12-14 | SEC Comment Letter | NEKTAR THERAPEUTICS | DE | N/A | Read Filing View |
| 2017-11-01 | SEC Comment Letter | NEKTAR THERAPEUTICS | DE | N/A | Read Filing View |
| 2011-08-26 | SEC Comment Letter | NEKTAR THERAPEUTICS | DE | N/A | Read Filing View |
| 2011-07-28 | SEC Comment Letter | NEKTAR THERAPEUTICS | DE | N/A | Read Filing View |
| 2009-02-23 | SEC Comment Letter | NEKTAR THERAPEUTICS | DE | N/A | Read Filing View |
| 2009-02-13 | SEC Comment Letter | NEKTAR THERAPEUTICS | DE | N/A | Read Filing View |
| 2008-12-10 | SEC Comment Letter | NEKTAR THERAPEUTICS | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-03-28 | Company Response | NEKTAR THERAPEUTICS | DE | N/A | Read Filing View |
| 2024-06-03 | Company Response | NEKTAR THERAPEUTICS | DE | N/A | Read Filing View |
| 2021-11-09 | Company Response | NEKTAR THERAPEUTICS | DE | N/A | Read Filing View |
| 2018-12-07 | Company Response | NEKTAR THERAPEUTICS | DE | N/A | Read Filing View |
| 2017-12-27 | Company Response | NEKTAR THERAPEUTICS | DE | N/A | Read Filing View |
| 2017-11-20 | Company Response | NEKTAR THERAPEUTICS | DE | N/A | Read Filing View |
| 2017-11-15 | Company Response | NEKTAR THERAPEUTICS | DE | N/A | Read Filing View |
| 2011-08-11 | Company Response | NEKTAR THERAPEUTICS | DE | N/A | Read Filing View |
| 2009-02-19 | Company Response | NEKTAR THERAPEUTICS | DE | N/A | Read Filing View |
| 2009-01-26 | Company Response | NEKTAR THERAPEUTICS | DE | N/A | Read Filing View |
| 2009-01-14 | Company Response | NEKTAR THERAPEUTICS | DE | N/A | Read Filing View |
| 2008-12-18 | Company Response | NEKTAR THERAPEUTICS | DE | N/A | Read Filing View |
2025-03-28 - CORRESP - NEKTAR THERAPEUTICS
CORRESP 1 filename1.htm CORRESP VIA EDGAR March 28, 2025 United States Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attention: Lauren Hamill Re: Nektar Therapeutics Acceleration Request for Registration Statement on Form S-3 File No. 333-286222 Dear Laura Hamill, Pursuant to Rule 461 under the Securities Act of 1933, as amended (the “ Act ”), Nektar Therapeutics (the “ Company ”) hereby requests that the effective date of the above-referenced registration statement (the “ Registration Statement ”) be accelerated to April 1, 2025, at 4:05 p.m., Eastern Time, or as soon thereafter as practicable, unless we or our outside counsel, Goodwin Procter LLP, request by telephone that such Registration Statement be declared effective at some other time. In making this acceleration request, the Company acknowledges that it is aware of its responsibilities under the Act. Once the Registration Statement is effective, please orally confirm the event with our counsel, Goodwin Procter LLP, by calling Justin Platt at (212) 459-7340. If you have any questions regarding this request, please contact Sam Zucker of Goodwin Procter LLP at (650) 752-3232 or Justin Platt at (212) 459-7340. Sincerely, NEKTAR THERAPEUTICS /s/ Howard W. Robin Howard W. Robin President and Chief Executive Officer cc: Howard W. Robin, Nektar Therapeutics Sam Zucker, Goodwin Procter LLP Justin Platt, Goodwin Procter LLP
2025-03-20 - UPLOAD - NEKTAR THERAPEUTICS File: 377-07788
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> March 20, 2025 Howard Robin Chief Executive Officer Nektar Therapeutics 455 Mission Bay Boulevard South San Francisco, CA 94158 Re: Nektar Therapeutics Draft Registration Statement on Form S-3 Submitted March 14, 2025 CIK No. 0000906709 Dear Howard Robin: This is to advise you that we do not intend to review your registration statement. We request that you publicly file your registration statement no later than two business days prior to the requested effective date and time. Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Please contact Lauren Hamill at 303-844-1008 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Justin Platt </TEXT> </DOCUMENT>
2024-06-03 - CORRESP - NEKTAR THERAPEUTICS
CORRESP 1 filename1.htm CORRESP VIA EDGAR June 3, 2024 United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Ms. Tamika Sheppard Re: Nektar Therapeutics Acceleration Request for Registration Statement on Form S-3 File No. 333-279760 Acceleration Request Requested Date: June 5, 2024 Requested Time: 4:05 p.m., Eastern Time Dear Ms. Sheppard: Pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Act”), Nektar Therapeutics (the “Company”) hereby requests that the effective date of the above-referenced registration statement (the “Registration Statement”) be accelerated to June 5, 2024, at 4:05 p.m., Eastern Time, or as soon thereafter as practicable, unless we or our outside counsel, Goodwin Procter LLP, request by telephone that such Registration Statement be declared effective at some other time. In making this acceleration request, the Company acknowledges that it is aware of its responsibilities under the Act. Once the Registration Statement is effective, please orally confirm the event with our counsel, Goodwin Procter LLP, by calling Sam Zucker at (650) 752-3232. If you have any questions regarding this request, please contact Sam Zucker of Goodwin Procter LLP at (650) 752-3232. Sincerely, NEKTAR THERAPEUTICS /s/ Mark A. Wilson Mark A. Wilson General Counsel Nektar Therapeutics cc: Howard W. Robin, Chief Executive Officer, President and Director, Nektar Therapeutics Sandra Gardiner, Chief Financial Officer, Nektar Therapeutics Mitchell S. Bloom, Esq., Goodwin Procter LLP Sam Zucker, Esq., Goodwin Procter LLP
2024-05-31 - UPLOAD - NEKTAR THERAPEUTICS File: 333-279760
United States securities and exchange commission logo
May 31, 2024
Mark Wilson
General Counsel
Nektar Therapeutics
455 Mission Bay Boulevard South
San Francisco, CA 94158
Re:Nektar Therapeutics
Registration Statement on Form S-3
Filed May 28, 2024
File No. 333-279760
Dear Mark Wilson:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Tamika Sheppard at 202-551-8346 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Mitchell Bloom
2021-12-13 - UPLOAD - NEKTAR THERAPEUTICS
United States securities and exchange commission logo
December 13, 2021
Gil M. Labrucherie
Chief Operating Officer and Chief Financial Officer
Nektar Therapeutics
455 Mission Bay Boulevard South
San Francisco, CA 94158
Re:Nektar Therapeutics
Form 10-K for the Fiscal Year Ended December 31, 2020
Filed February 26, 2021
File Number 000-24006
Dear Mr. Labrucherie:
We have completed our review of your filing. We remind you that the company and its
management are responsible for the accuracy and adequacy of their disclosures, notwithstanding
any review, comments, action or absence of action by the staff.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2021-11-09 - CORRESP - NEKTAR THERAPEUTICS
CORRESP
1
filename1.htm
Nektar Therapeutics
455 Mission Bay Boulevard South
San Francisco, California 94158-2117
November 9, 2021
VIA EDGAR
Office of Life Sciences
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attention: Mary Mast, Senior Staff Accountant
Re:
Nektar Therapeutics
Form 10-K for the Fiscal Year Ended December 31, 2020
Filed February 26, 2021
Form 10-Q for the Quarterly Period Ended June 30, 2021
Filed August 6, 2021
File No. 000-24006
Dear Ms. Mast:
We are in receipt of the letter from the staff
(the “Staff”) of the Securities and Exchange Commission (the “Commission”) dated October 26, 2021,
regarding the Annual Report on Form 10-K for the fiscal year ended December 31, 2020 (File No. 000-24006) and the Quarterly Report on
Form 10-Q for the quarterly period ended June 30, 2021 (File No. 000-24006) filed by Nektar Therapeutics, a Delaware corporation (the
“Company” or “we”), on February 26, 2021 and August 6, 2021, respectively. Set forth below is the
Company’s response to the Staff’s comment set forth in the letter.
Staff Comment:
Form 10-Q for the Quarterly Period Ended June
30, 2021
Note 4 – Co-Development Agreement with SFJ Pharmaceuticals
and Development Derivative Liability, page 16
1. Please provide us with your accounting analysis supporting the classification of this co-development agreement as a derivative
liability. As part of your response, please explain how you determined the agreement met the definition of a derivative under ASC 815
as well as your consideration of any applicable scope exceptions. Please also explain how you determined that changes in the fair value
of your development derivative liability should be classified as non-operating income/expense in your Statement of Operations given that
product development is integral to your operations.
Response:
With regard to the Staff’s comment about
our treatment of the SFJ co-development agreement (the “SFJ Agreement”), we respectfully advise the Staff that, as
we have previously disclosed in our public filings, SFJ and we have agreed that SFJ will fund up to $150.0 million (the “Funding
Commitment”) to conduct a Phase 2/3 study in squamous cell cancer of the head and neck (the “SCCHN Indication” and
the “SCCHN Clinical Trial”). We are the sponsor for the SCCHN Clinical Trial, responsible for developing the protocol,
data analysis, pharmacovigilance and regulatory activities, including filing the Biologics License Application (“BLA”),
if the SCCHN Clinical Trial is successful. SFJ will act as our contract research organization (“CRO”) but will primarily
outsource such responsibilities to PPD, which has been our CRO for our bempegaldesleukin program, as well as other third-party vendors.
SFJ’s Funding Commitment also includes quarterly payments to us since we are providing resources to conduct the SCCHN Clinical Trial.
As we have previously disclosed in our public filings, in exchange
for the Funding Commitment, we will pay SFJ a series of success-based annual payments (collectively, the “Success Payments”)
of up to $637.5 million in the event of FDA approval of bempegaldesleukin for first-line metastatic melanoma1 (the “Melanoma Indication”), the SCCHN Indication,
or both, and in the
event of FDA approval of one additional bempegaldesleukin indication. The SCCHN Clinical Trial also provides for an interim futility analysis.
If the success criterion for the interim futility analysis is not met and SFJ winds down the SCCHN Clinical Trial, then the Success Payments,
if any, for the Melanoma Indication and/or the additional bempegaldesleukin indication are reduced pro rata based on the costs incurred
by SFJ for the SCCHN Clinical Trial over the aggregate commitment of $150.0 million. In the event that bempegaldesleukin is not approved
in one or more indications, SFJ will bear the full cost of conducting the clinical trial and has no right to be reimbursed by Nektar.
The Success Payments for the Melanoma Indication
and an additional bempegaldesleukin indication are based on registrational trials for bempegaldesleukin in combination with nivolumab
under our Strategic Collaboration Agreement with Bristol Myers-Squibb Company (“BMS”). SFJ has no decision-making rights
or any involvement in the conduct of this collaboration, the clinical trials or the filing of a BLA for these indications. Because SFJ
has a right to consideration based on the results of these studies, we concluded that the SFJ Agreement is outside the scope of a collaborative
or research and development arrangement and determined that it is a financing arrangement. SFJ is investing in the overall bempegaldesleukin
program through its funding of a trial for which we have no prior efficacy data, and, in return for this risk, has the opportunity to
earn a return on investment based on the overall success of bempegaldesleukin, as measured by potential future FDA approvals.
1 The registrational study for first-line metastatic melanoma
is being conducted by Bristol Myers-Squibb Company pursuant to our Strategic Collaboration Agreement, as disclosed in Note 8 to our Form
10-Q for the Quarterly Period Ended June 30, 2021.
2
In our assessment of whether these terms met the
definition of a derivative, we considered the definition of a derivative provided by ASC 815-10-15-83, and the related guidance on an
underlying, notional amount, payment provision and initial net investment.
815-10-15-83: A derivative instrument
is a financial instrument or other contract with all of the following characteristics:
a. Underlying, notional amount, payment
provision. The contract has both of the following terms, which determine the amount of the settlement or settlements, and, in some cases,
whether or not a settlement is required:
1.One or more underlyings.
2. One or more notional amounts or
payment provisions or both.
b. Initial net investment. The contract
requires no initial net investment or an initial net investment that is smaller than would be required for other types of contracts that
would be expected to have a similar response to changes in market factors.
c. Net settlement. The contract can
be settled net by any of the following means:
1. Its terms implicitly or explicitly
require or permit net settlement.
2. It can readily be settled net
by a means outside the contract.
3. It provides for delivery of an
asset that puts the recipient in a position not substantially different from net settlement.
Underlying
815-10-15-88: An underlying is a
variable that, along with either a notional amount or a payment provision, determines the settlement of a derivative instrument. An underlying
usually is one or a combination of the following:
a. A security price or security price
index
b. A commodity price or commodity price
index
c. An interest rate or interest rate
index
d. A credit rating or credit index
e. An exchange rate or exchange rate
index
f. An insurance index or catastrophe
loss index
g. A climatic or geological condition
(such as temperature, earthquake severity, or rainfall), another physical variable, or a related index
h. The occurrence or nonoccurrence
of a specified event (such as a scheduled payment under a contract).
15-89: However, an underlying may
be any variable whose changes are observable or otherwise objectively verifiable. An underlying may be a price or rate of an asset or
liability but is not the asset or liability itself.
15-90: Reference to either a notional
amount or a payment provision is needed in relation to an underlying to compute the contract's periodic settlements and resulting changes
in fair value.
Notional Amount
815-10-15-92: A notional amount is
a number of currency units, shares, bushels, pounds, or other units specified in the contract. Other names are used, for example, the
notional amount is called a face amount in some contracts. The settlement of a derivative instrument with a notional amount is determined
by interaction of that notional amount with the underlying. The interaction may be simple multiplication, or it may involve a formula
with leverage factors or other constants. As defined in the glossary, the effective notional amount is the stated notional amount adjusted
for any leverage factor. If a requirements contract contains explicit provisions that support the calculation of a determinable amount
reflecting the buyer’s needs, then that contract has a notional amount. See paragraphs 815-10-55-5 through 55-7 for related implementation
guidance. For implementation guidance on identifying a commodity contract's notional amount, see paragraph 815-10-55-5.
3
Payment Provision
815-10-15-93: As defined in the glossary,
a payment provision specifies a fixed or determinable settlement to be made if the underlying behaves in a specified manner. For example,
a derivative instrument might require a specified payment if a referenced interest rate increases by 300 basis points.
Initial Net Investment
815-10-15-94: Many derivative instruments
require no initial net investment. Some require an initial net investment as compensation for one or both of the following:
a. Time value (for example, a premium
on an option)
b. Terms that are more or less favorable
than market conditions (for example, a premium on a forward purchase contract with a price less than the current forward price).
Others require a mutual exchange
of currencies or other assets at inception, in which case the net investment is the difference in the fair values of the assets exchanged.
15-95: A derivative instrument
does not require an initial net investment in the contract that is equal to the notional amount (or the notional amount plus a premium
or minus a discount) or that is determined by applying the notional amount to the underlying. For example:
a. A commodity futures contract generally
requires no net investment, while purchasing the same commodity requires an initial net investment equal to its market price. However,
both contracts reflect changes in the price of the commodity in the same way (that is, similar gains or losses will be incurred).
b. A swap or forward contract generally
does not require an initial net investment unless the terms favor one party over the other.
c. An option generally requires that
one party make an initial net investment (a premium) because that party has the rights under the contract and the other party has the
obligations.
15-96: If the initial net investment
in the contract (after adjustment for the time value of money) is less, by more than a nominal amount, than the initial net investment
that would be commensurate with the amount that would be exchanged either to acquire the asset related to the underlying or to incur the
obligation related to the underlying, the characteristic in paragraph 815-10-15-83(b) is met. The amount of that asset acquired or liability
incurred should be comparable to the effective notional amount of the contract. This does not imply that a slightly off-market contract
cannot be a derivative instrument in its entirety. That determination is a matter of facts and circumstances and shall be evaluated on
a case-by-case basis. Example 16, Case C (see paragraph 815-10-55-166) illustrates the guidance in this paragraph.
We concluded that the SFJ Agreement contains the
following four key elements of a derivative as follows:
● Underlying: The underlyings are the FDA approvals of bempeg in the Melanoma Indication, the SCCHN Indication and another bempegaldesleukin
indication, as these approvals trigger the Success Payments, which represent SFJ’s opportunity to earn a return on its investment
(payment provision). While the FDA approvals of bempegaldesleukin in the Melanoma Indication and another bempegaldesleukin indication
are not related to the conduct of the SCCHN Clinical Trial, there is no requirement that an underlying be related to the consideration
provided by SFJ. This type of underlying is consistent with ASC 815-10-15-88(h) for the “occurrence or nonoccurrence of a specified
event,” in this case, the FDA approval or non-approval of one or more bempegaldesleukin BLAs.
4
● Notional amount or payment provision: The SFJ Agreement contains a payment provision because it specifies fixed payment amounts
of up to $637.5 million and the timing of the payments over up to a seven-year period based on the occurrence of the FDA approvals.
● No initial or nominal net investment: SFJ is not required to and did not make a payment to us at inception, so this requirement
has been met. However, we note that SFJ has agreed to the Funding Commitment, which is the consideration in the contract. Accordingly,
in theory, if SFJ were to pay us the fair value of the Funding Commitment at inception, we would be in the same economic position. As
such, we considered whether this amount of consideration/investment would continue to meet the requirement of ASC 815-10-15-83(b), and
note that, since SFJ has the rights to receive the Success Payments and we have the obligation to pay the Success Payments, the arrangement
is similar to an option as described in ASC 815-10-15-95(c). Given the magnitude of the Success Payments of $637.5 million as compared
to the estimated $114.5 million fair value of Funding Commitment, we concluded that this investment is significantly less than the amount
“to incur the obligation related to the underlying” after considering the time value of money, as described in ASC 815-10-15-96.
Accordingly, whether one considers the initial net investment to be $0 or the fair value of the Funding Commitment, the requirement in
ASC 815-10-15-83(b) is met.
● Net settlement provision: We are required to pay the Success Payments to SFJ, as the Success Payments represent the payment
provision based on the underlying of the FDA approval of bempegaldesleukin. Since the payment is unidirectional, it can only represent
a net settlement provision. We concluded that we should not consider the Funding Commitment in our analysis of the net settlement provision,
since it represents the consideration/nominal net investment in the contract.
With respect to the scope exceptions for ASC 815-10,
as provided in ASC 815-10-15-13, we believe that it is evident that none of the scope exceptions would apply to the SFJ Agreement, other
than ASC 815-10-15-13(e) for “Certain contracts that are not traded on an exchange.” Accordingly, we analyzed the guidance
in ASC 815-10-15-59 for the application of this scope exception, which states “Contracts that are not exchange-traded are not subject
to the requirements of this Subtopic if the underlying on which the settlement is based is any one of the following:”
5
a. A climatic or geological variable or other physical variable. Climatic, geological, and other physical variables include things like the number of inches of rainfall or snow in a particular area and the severity of an earthquake as measured by the Richter scale. (See Example 13 [paragraph 815-10-55-135].)
No, the FDA approval of bempegaldesleukin is the underlying, which is not a climatic, geological or other physical variable.
b. The price or value of a nonfinancial asset of one of the parties
to the contract provided that the asset is not readily convertible to cash. This scope exception applies only if both of the following
are true:
1. The nonfinancial assets are unique.
2. The nonfinancial asset related to the underlying is
owned by the party that would not benefit under the contract from an increase in the fair value of the nonfinancial asset. (If the contract
is a call option, the scope exception applies only if that nonfinancial asset is owned by the party that would not benefit under the contract
from an increase in the fair value of the nonfinancial asset above the option’s strike p
2021-10-26 - UPLOAD - NEKTAR THERAPEUTICS
United States securities and exchange commission logo
October 26, 2021
Gil M. Labrucherie
Chief Operating Officer and Chief Financial Officer
Nektar Therapeutics
455 Mission Bay Boulevard South
San Francisco, CA 94158
Re:Nektar Therapeutics
Form 10-K for the Fiscal Year Ended December 31, 2020
Filed February 26, 2021
Form 10-Q for the Quarterly Period Ended June 30, 2021
Filed August 6, 2021
File Number 000-24006
Dear Mr. Labrucherie:
We have limited our review of your filing to the financial statements and related
disclosures and have the following comment.
Please respond to the comment within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe our
comment applies to your facts and circumstances, please tell us why in your response.
After reviewing your response to the comment, we may have additional comments.
Form 10-Q for Quarterly Period Ended June 30, 2021
Notes to Condensed Consolidated Financial Statements
Note 4 - Co-Development Agreement with SFJ Pharmaceuticals and Development Derivative
Liability, page 16
1.Please provide us with your accounting analysis supporting the classification of this co-
development agreement as a derivative liability. As part of your response, please explain
how you determined the agreement met the definition of a derivative under ASC 815 as
well as your consideration of any applicable scope exceptions. Please also explain how
you determined that changes in the fair value of your development derivative liability
should be classified as non-operating income/expense in your Statement of Operations
given that product development is integral to your operations.
In closing, we remind you that the company and its management are responsible for the
FirstName LastNameGil M. Labrucherie
Comapany NameNektar Therapeutics
October 26, 2021 Page 2
FirstName LastName
Gil M. Labrucherie
Nektar Therapeutics
October 26, 2021
Page 2
accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or
absence of action by the staff.
You may contact Mary Mast at 202-551-3613 or Angela Connell, Branch Chief, at 202-
551-3426 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2019-02-08 - UPLOAD - NEKTAR THERAPEUTICS
February 7, 2019
Gil M. Labrucherie
Senior Vice President and Chief Financial Officer
Nektar Therapeutics
455 Mission Bay Boulevard South
San Francisco, CA 94158
Re:Nektar Therapeutics
Form 10-K for the Fiscal Year Ended December 31, 2017
Filed March 1, 2018
File No. 000-24006
Dear Mr. Labrucherie:
We have completed our review of your filing. We remind you that the company and its
management are responsible for the accuracy and adequacy of their disclosures, notwithstanding
any review, comments, action or absence of action by the staff.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
2018-12-07 - CORRESP - NEKTAR THERAPEUTICS
CORRESP 1 filename1.htm CORRESP Nektar Therapeutics 455 Mission Bay Boulevard South San Francisco, California 94158-2117 December 7, 2018 VIA EDGAR Office of Healthcare and Insurance United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Mary Mast Re: Nektar Therapeutics Form 10-K for the Fiscal Year Ended December 31, 2017 Filed March 1, 2018 File No. 000-24006 Dear Ms. Mast: We are in receipt of the letter from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) dated November 19, 2018, regarding the Annual Report on Form 10-K for the fiscal year ended December 31, 2017 (File No. 000-24006) and the Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2018 (File No. 000-24006) filed by Nektar Therapeutics, a Delaware corporation (the “Company” or “we”), on March 1, 2018 and November 8, 2018, respectively. Set forth below is the Company’s response to the Staff’s comment set forth in the letter. We respectfully request, pursuant to 17 C.F.R. §200.83, that the Commission 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 Company is concurrently delivering an unredacted hard copy of its response to the Commission. Staff Comment: Form 10-Q for the nine months ended September 30, 2018 Note 6 – License and Collaboration Agreements Bristol-Meyers Squibb (BMS), page 15 *** Information omitted and provided under separate cover to the Staff pursuant to 17 C.F.R. §200.83 1 1. On February 13, 2018 you entered into the BMS collaboration agreement to jointly develop and commercialize NKTR-214. You state that you identified two performance obligations, consisting of the delivery of the licenses and your participation on joint steering and other collaboration committees. Your accounting policy on page 9 states that for collaboration arrangements with multiple performance obligations, such as granting a license and performing research and development activities, you allocate the upfront and milestone payments under a relative standalone selling price method. It is not clear why amounts for research and development in the BMS agreement are not considered a performance obligation nor why, as you state on page 15, that you record cost reimbursement payments to you from BMS as a reduction of research and development expense rather than as revenue. It appears to us that your separation, measurement, allocation and classification of amounts related to the BMS agreement is inconsistent with your accounting policy on page 9 and with your accounting for your agreement with Lilly. Please provide us an analysis with reference to authoritative literature supporting your accounting for the BMS agreement. Also, provide us proposed revised accounting policy disclosure to be included in future filings addressing this inconsistency or tell us why revised disclosure is not necessary. Response: In regards to the Staff’s comment on our treatment of the BMS collaboration agreement, we respectfully advise the Staff that BMS and we have agreed to jointly develop NKTR-214 in oncology indications, primarily in combination with BMS’ Opdivo and Yervoy. If NKTR-214 receives regulatory approval, BMS and we will jointly commercialize it. BMS agreed to purchase licenses for the development and commercialization of NKTR-214 along with a 35% economic interest in NKTR-214. As a result, BMS is responsible for 35% of the development costs of NKTR-214 and, if NKTR-214 is approved by regulatory authorities, will receive 35% of the net commercialization profits. Likewise, we have retained our 65% economic interest in NKTR-214 and are responsible for 65% of the development costs and, if NKTR-214 is approved by regulatory authorities, will retain 65% of the net commercialization profits. However, we have no economic interest in either of the BMS compounds described above, and BMS has no ownership rights in NKTR-214 to independently commercialize the compound. This is fundamentally different than other arrangements we have entered into with other collaboration partners. With respect to the development activities under the collaboration, BMS and we are jointly developing NKTR-214 in combination therapies. In this development program, we are responsible for conducting certain of the studies planned to be performed under the agreement, and BMS is responsible for conducting the remaining studies. The benefits from these studies accrue to NKTR-214 development and are not services rendered on BMS’ behalf. In accordance with the agreement, BMS and we reimburse each other for each party’s share of the counterparty’s costs incurred. Furthermore, under the agreement, the parties can change which party leads a particular study or increase the number of studies. Accordingly, the costs ultimately borne by BMS and us are based on each party’s respective economic interest in the compound and are not based on which party incurs the costs. As such, and as further explained below, we do not have a vendor-customer relationship with BMS with respect to development activities and do not view our execution of development services as performing services on BMS’ behalf. Rather, each party is contributing both personnel and financial resources at the level required to maintain the cost sharing percentages consistent with its economic interests. Therefore, we do not consider BMS’ reimbursements of our costs to be revenue. *** Information omitted and provided under separate cover to the Staff pursuant to 17 C.F.R. §200.83 2 With respect to the cost-sharing aspect of the arrangement, we respectfully advise the Staff that the development and commercialization cost sharing percentages under the agreement are consistent with each party’s economic interests in the compounds, as described above. For example, for the costs of production of NKTR-214, we bear 65% of the costs, and BMS bears 35%, and for the costs of production of BMS’ Opdivo, BMS bears all costs. [***] [***] This underlying cost-sharing arrangement is consistent throughout the agreement, and, as a result, BMS bears 35% of the development costs of NKTR-214 and, if commercialized, will receive 35% of the net profits of NKTR-214. We are also studying NKTR-214 in combination with compounds other than Opdivo, including other Nektar and other third-party compounds. Given the terms of the BMS collaboration agreement, we concluded that it is within the scope of ASC 808-10 Collaborative Arrangements (ASC 808) because the development and potential commercialization of NKTR-214 represent a joint operating activity, wherein both parties meet the requirements of active participation provided in ASC 808-10-15-8, and both parties are exposed to significant risks and rewards. More importantly, we believe that this is a collaboration arrangement at its most fundamental level. Both parties have rights in the decision-making process for further development of NKTR-214, and, even if the parties change responsibilities, e.g. the parties agree to change the lead party for a given study as described above, the economics of the cost sharing do not change. To determine the appropriate presentation of payments from BMS to us, we considered ASC 808-10-45-4, which states: An entity shall evaluate the income statement classification of payments between participants pursuant to a collaborative arrangement based on the nature of the arrangement, the nature of its business operations, the contractual terms of the arrangement, and whether those payments are within the scope of other authoritative accounting literature on income statement classification. If the payments are within the scope of other authoritative accounting literature, then the entity shall apply the relevant provisions of that literature. To the extent that these payments are not within the scope of other authoritative accounting literature, the income statement classification for the payments shall be based on an analogy to authoritative accounting literature or if there is no appropriate analogy, a reasonable, rational, and consistently applied accounting policy election. For example, if one party to an arrangement is required to make a payment to the other party to reimburse a portion of that party’s research and development cost, that portion of the net payment may be classified as research and development expense in the payor’s financial statements pursuant to Topic 730. *** Information omitted and provided under separate cover to the Staff pursuant to 17 C.F.R. §200.83 3 Accordingly, we would only account for payments from BMS to us under ASC 606-10 Revenue from Contracts with Customers (ASC 606) to the extent that such payments fall within the scope of ASC 606. We note that ASC 808-10-55 provides for reimbursement payments that are not accounted for as revenue to be recorded as a reduction of research and development expense. ASC 808-10-55-8 illustrates the guidance in ASC 808-10-45 with an example and states, in part: Pharma has concluded that other authoritative accounting literature does not apply to these payments, either directly or by analogy, and, accordingly, its accounting policy is to evaluate the income statement classification for amounts due from or owed to other participants associated with multiple activities in a collaborative arrangement based on the nature of each separate activity. As a result, Pharma disaggregates the $13.75 million net payable to Biotech in accordance with the nature of the individual components of the payable and characterizes the portion of the payable related to 50 percent of the commercialization activities (sales to third parties less associated manufacturing and marketing costs) as cost of sales ($16.25 million). Pharma characterizes the portion of the net payable related to research and development activities as a reduction of its research and development expenses ($2.5 million), because performing contract research and development services is not part of its ongoing major or central operations. Additionally, the example in ASC 808-10-55-13 states, in part: Little Pharma has concluded that other authoritative accounting literature does not apply to these payments, either directly or by analogy, and, accordingly, its accounting policy is to evaluate the income statement classification for payments associated with each separate activity. As a result, Little Pharma disaggregates its $4.75 million net payable to Big Pharma in accordance with the nature of the individual item and characterizes a portion of the net payable related to 35 percent of the profit related to the sales in the United States as expenses from collaborative arrangement ($22.75 million) and characterizes the portion of the net payable to Big Pharma for research and development activities as research and development expenses. Little Pharma concludes that the portion of the net payable related to profit sharing from Big Pharma’s sales in Europe and Asia is analogous to a royalty and therefore should characterize the $10.5 million as revenue similar to a royalty. Little Pharma also concludes that any payment from Big Pharma for research and development activities will be characterized as a reduction of its research and development costs ($7.5 million) because performing contract research and development services is not part of its ongoing major or central operations. In considering whether and which payments from BMS to us fall under ASC 606, we note that ASC 606-10-15-3 requires that the counterparty be a customer and the ASC Master Glossary defines customer as “a party that has contracted with an entity to obtain goods or services that are an output of the entity’s ordinary activities in exchange for consideration.” We also considered the definition of revenues in Statement of Financial Accounting Concepts No. 6, paragraph 78, which states: *** Information omitted and provided under separate cover to the Staff pursuant to 17 C.F.R. §200.83 4 Revenues are inflows or other enhancements of assets of an entity or settlements of its liabilities (or a combination of both) from delivering or producing goods, rendering services, or other activities that constitute the entity’s ongoing major or central operations. In considering the above definitions of customer and revenues, we consider our ongoing central operations to be the research and development of our drug candidates for potential commercialization. We may, at times, enter into out-license arrangements for our drug candidates, wherein we may perform contracted development services and the licensee will use the output of these services for its future development of the drug candidate. If there is a vendor-customer relationship for both the license and the contracted development services, we analogize to the revenue literature for both elements. However, as discussed further below, we concluded that BMS does not obtain the output of our development activities of NKTR-214 and therefore does not represent a customer for these activities. Accordingly, we do not analogize to the revenue literature for the related development cost reimbursement payments. With respect to granting licenses, we concluded that granting licenses to BMS for the development and commercialization of NKTR-214 represented a performance obligation since we grant licenses in the ordinary course of business and BMS’ 35% interest in the net profits of NKTR-214 provided BMS an ability to monetize the value of the licenses. [***] We also note that the BMS treatment of its upfront payment to us is consistent: BMS expensed its payment to us for its rights, rather than recognizing any portion of the upfront payment as prepaid research and development expense.1 With respect to this arrangement’s cost-sharing reimbursements for research and development activities, we do not believe that the arrangement is consistent with a vendor-customer relationship where the vendor agrees to perform specific development activities for the primary benefit of the customer, considering that we would only be reimbursed for 35% of our costs for any incremental activities that we incur. Furthermore, the development activities performed by both BMS and us benefit the development of NKTR-214 for which we continue to have full rights to the underlying intellectual property as well as full rights to manufacture, develop and sell. As such, BMS is not directly obtaining the output of our development activities as there has been no transfer of a good or service to BMS, and, therefore, BMS does not represent a customer for such activities. Furthermore, BMS has full economic exposure for 35% of the costs incurred for the development of NKTR-214, which is consistent with their economic interest. As a result, we concluded that we should continue to account for the development activities as collaborative activities under ASC 808. We also believe that the consistent sharing of costs and profits for NKTR-214 further supports this conclusion in that a vendor-customer relationship does not exist between two parties with partnership-like interests in NKTR-214. Accordingly, we considered ASC 808-10-45-4, as quoted above, and concluded that it is appropriate to present the payments from BMS to us for development activities as a reduction of research and development costs, which is consistent with the implementation guidance in ASC 808-10-55-8 and 55-13, quoted
2018-11-19 - UPLOAD - NEKTAR THERAPEUTICS
November 19, 2018
Gil M. Labrucherie
Senior Vice President and Chief Financial Officer
NEKTAR THERAPEUTICS
455 Mission Bay Boulevard South
San Francisco, CA 94158
Re:NEKTAR THERAPEUTICS
Form 10-K for the Fiscal Year Ended December 31, 2017
Filed March 1, 2018
File No. 000-24006
Dear Mr. Labrucherie:
We have limited our review of your filing to the financial statements and related
disclosures and have the following comment. In our comment, we may ask you to provide us
with information so we may better understand your disclosure.
Please respond to the comment within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe our
comment applies to your facts and circumstances, please tell us why in your response.
After reviewing your response to the comment, we may have additional comments.
Form 10-Q for the nine months ended September 30, 2018
Notes to the Consolidated Financial Statements
Note 6 - License and Collaboration Agreements
Bristol-Myers Squibb (BMS), page 15
1.On February 13, 2018 you entered into the BMS collaboration agreement to jointly
develop and commercialize NKTR-214. You state that you identified two performance
obligations, consisting of the delivery of the licenses and your participation on joint
steering and other collaboration committees. Your accounting policy on page 9 states that
for collaboration arrangements with multiple performance obligations, such as granting a
license and performing research and development activities, you allocate the upfront and
milestone payments under a relative standalone selling price method. It is not clear why
amounts for research and development in the BMS agreement are not considered a
performance obligation nor why, as you state on page 15, that you record cost
reimbursement payments to you from BMS as a reduction of research and development
FirstName LastNameGil M. Labrucherie
Comapany NameNEKTAR THERAPEUTICS
November 19, 2018 Page 2
FirstName LastName
Gil M. Labrucherie
NEKTAR THERAPEUTICS
November 19, 2018
Page 2
expense rather than as revenue. It appears to us that your separation, measurement,
allocation and classification of amounts related to the BMS agreement is inconsistent with
your accounting policy on page 9 and with your accounting for your agreement with Lilly.
Please provide us an analysis with reference to authoritative literature supporting your
accounting for the BMS agreement. Also, provide us proposed revised accounting policy
disclosure to be included in future filings addressing this inconsistency or tell us why
revised disclosure is not necessary.
In closing, we remind you that the company and its management are responsible for the
accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or
absence of action by the staff.
You may contact Mary Mast at (202) 551-3613 or Lisa Vanjoske at (202) 551-3614 with
any questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
2018-01-16 - UPLOAD - NEKTAR THERAPEUTICS
January 16, 2018
Gil M. Labrucherie
Senior Vice President and Chief Financial Officer
Nektar Therapeutics
455 Mission Bay Boulevard South
San Francisco, California 94158
Nektar Therapeutics
Form 10-K for the Fiscal Year Ended December 31, 2016
Filed March 1, 2017
File No. 000-24006Re:
Dear Mr. Labrucherie:
We have completed our review of your filings. We remind you that the company and its
management are responsible for the accuracy and adequacy of their disclosures, notwithstanding
any review, comments, action or absence by the staff.
Division of Corporation Finance
Office of Healthcare & Insurance
2017-12-27 - CORRESP - NEKTAR THERAPEUTICS
CORRESP 1 filename1.htm CORRESP Nektar Therapeutics 455 Mission Bay Boulevard South San Francisco, California 94158-2117 December 27, 2017 VIA EDGAR Office of Healthcare and Insurance United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Ibolya Ignat, Senior Staff Accountant Re: Nektar Therapeutics Form 10-Q for the Quarterly Period Ended September 30, 2017 Filed November 8, 2017 File No. 000-24006 Dear Ms. Ignat: We are in receipt of the letter from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) dated December 14, 2017, regarding the Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2017 (File No. 000-24006) filed by Nektar Therapeutics, a Delaware corporation (the “Company” or “we”), on November 8, 2017 (the “Form 10-Q”). Set forth below is the Company’s response to the Staff’s comment set forth in the letter. We respectfully request, pursuant to 17 C.F.R. §200.83, that the Commission 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 Company is concurrently delivering an unredacted hard copy of its response to the Commission. Staff Comment: Form 10-Q for the Quarterly Period Ended September 30, 2017 Note 6 – License and Collaboration Agreements, page 15 1. As it relates to your August 23, 2017 license agreement with Eli Lilly to co-develop NKTR-358, please provide us with your accounting analysis under ASC 605-25-25-5(a) supporting your determination that the license granted to Eli Lilly has stand-alone value and therefore represents a separate unit-of-account. Specifically address how you were able to separate the license from your Phase 1 clinical development obligation. 1 Response: We respectfully advise the Staff that, in our consideration of whether the license has standalone value, we note that the license grant was delivered to Eli Lilly (“Lilly”) upon the effective date, August 23, 2017, of our license agreement with Lilly (the “License Agreement”). We note that ASC 605-25-25-5(a) states, “The item or items have value on a standalone basis if they are sold separately by any vendor or the customer could resell the delivered item(s) on a standalone basis. In the context of a customer’s ability to resell the delivered item(s), this criterion does not require the existence of an observable market for the deliverable(s).” We concluded that the license has standalone value due to Lilly’s sublicense rights and [***]. First, since NKTR-358 is a proprietary compound, we concluded that the license grant is not sold separately by any vendor, so it does not meet the first criterion of establishing standalone value in ASC 605-25-25-5(a). Next, we considered Lilly’s ability to resell the license to establish standalone value under the second criterion. We note that Lilly has the ability to sublicense NKTR-358 [***]. The License Agreement provides Lilly with a wide field of use for diseases or conditions whose treatment requires an elevation of a certain type of immune cell (called “T-regulatory cells”) to suppress an immune response, and based on our market research, NKTR-358 could be effective for [***]. With this wide field of use and ability to sublicense the compound [***], it is possible, but not certain, whether Lilly has the ability to substantially recover the $150 million upfront payment, in order to conclude that the license has standalone value under the second criterion. We also respectfully advise the Staff that our consideration of whether the license has standalone value also included [***]. We respectfully advise the Staff that we generally use third parties to perform much of the development services that are described in the License Agreement for our proprietary programs. Similarly, we use, or plan to use, third parties to perform a predominant majority of the development services to specifically fulfill our obligations under the License Agreement. We also respectfully advise the Staff that Lilly has extensive experience in developing therapies for autoimmune indications, and the License Agreement provides Lilly broad, exclusive rights to NKTR-358 to develop, make and have made, and commercialize the compound. [***]. Therefore, in our considerations of [***], we note: • NKTR-358 is a defined compound, and no further changes to it will result from the Phase 1 clinical development. • [***]. • [***]. 2 *** Information omitted and provided under separate cover to the Staff pursuant to 17 C.F.R. §200.83 • Under the terms of the License Agreement, if Nektar does not complete its Phase 1 clinical development by a certain date, Lilly has the option to assume responsibility for completing these trials. We believe this provides further evidence of Lilly’s ability to oversee Phase 1 clinical development. Based on the analysis above, we concluded that the license grant has standalone value to Lilly at the execution of the License Agreement and therefore represents a single unit-of-account. * * * * * The Company hereby acknowledges that: • the Company is responsible for the adequacy and accuracy of the disclosure in the filings; • 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. If you have additional questions, please do not hesitate to contact the undersigned at (415) 482-5570 or Jillian B. Thomsen, Senior Vice President, Finance and Chief Accounting Officer, at (415) 482-5555. Sincerely, /s/ Gil M. Labrucherie Gil M. Labrucherie Senior Vice President and Chief Financial Officer cc: Angela Connell, Accounting Branch Chief, Division of Corporation Finance Jillian B. Thomsen, Senior Vice President, Finance and Chief Accounting Officer of Nektar Therapeutics Mark A. Wilson, Vice President and General Counsel of Nektar Therapeutics Sam Zucker, Sidley Austin LLP 3
2017-12-14 - UPLOAD - NEKTAR THERAPEUTICS
December 14, 2017
Gil M. Labrucherie
Senior Vice President and Chief Financial Officer
Nektar Therapeutics
455 Mission Bay Boulevard South
San Francisco, California 94158
Re:Nektar Therapeutics
Form 10-K for the Fiscal Year Ended December 31, 2016
Filed March 1, 2017
Form 10-Q for the Quarterly Period Ended September 30, 2017
Filed November 8, 2017
File No. 000-24006
Dear Mr. Labrucherie:
We have reviewed your November 20, 2017 response to our comment letter as well as
your Form 10-Q for the quarterly period ended September 30, 2017 and have the following
comment. In our comment we may ask you to provide us with information so we may better
understand your disclosure.
Please respond to this comment within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe our
comment applies to your facts and circumstances, please tell us why in your response.
After reviewing your response to our comment, we may have additional comments.
Form 10-Q for Quarterly Period Ended September 30, 2017
Note 6 - License and Collaboration Agreements, page 15
1.As it relates to your August 23, 2017 license agreement with Eli Lilly to co-develop
NKTR-358, please provide us with your accounting analysis under ASC 605-25-25-5(a)
supporting your determination that the license granted to Eli Lilly has stand-alone value
and therefore represents a separate unit-of-account. Specifically address how you were
able to separate the license from your Phase 1 clinical development obligation.
FirstName LastNameGil M. Labrucherie
Comapany NameNektar Therapeutics
June 16, 2017 Page 2
FirstName LastName
Gil M. Labrucherie
Nektar Therapeutics
December 14, 2017
Page 2
You may contact Ibolya Ignat at (202) 551-3636 or Angela Connell at (202) 551-
3426 with any questions.
Division of Corporation Finance
Office of Healthcare & Insurance
2017-11-20 - CORRESP - NEKTAR THERAPEUTICS
CORRESP
1
filename1.htm
CORRESP
Nektar Therapeutics
455 Mission Bay Boulevard South
San Francisco, California 94158-2117
November 20, 2017
VIA EDGAR
Office of Healthcare and Insurance
United States Securities and
Exchange Commission
Division of Corporation Finance
100 F
Street, N.E.
Washington, D.C. 20549
Attention: Ibolya
Ignat, Senior Staff Accountant
Re:
Nektar Therapeutics
Form 10-K for the Fiscal Year Ended
December 31, 2016
Filed March 1, 2017
File No. 000-24006
Dear Ms. Ignat:
We are in receipt of the letter from the staff (the “Staff”) of the Securities and Exchange Commission (the
“Commission”) dated November 1, 2017, regarding the Annual Report on Form 10-K for the fiscal year ended December 31, 2016 (File
No. 000-24006) filed by Nektar Therapeutics, a Delaware corporation (the “Company” or “we”), on March 1, 2017 (the “Form 10-K”). Set forth below is the Company’s response to the Staff’s comment set forth in the letter.
We respectfully request, pursuant to 17 C.F.R. §200.83, that the Commission 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 Company is concurrently delivering an
unredacted hard copy of its response to the Commission.
Staff Comment:
Form 10-K for the Fiscal Year Ended December 31, 2016
Management’s Discussion and Analysis of Financial Condition and Results of Operations
Results of Operations
Cost of goods sold, page 50
1
1.
You disclose that you have a manufacturing arrangement with a partner that includes a fixed price which is less than the fully burdened manufacturing cost for the reagent and that you expect this situation with this
partner to continue in future years. Please tell us how you determined whether an adjustment to the cost basis of your inventory was warranted pursuant to ASC 330-10-35-1. Please also quantify for us the sales, cost of goods sold and gross profit for this product for your most recent annual and interim periods.
Response:
Background Information
In response to the Staff’s comment, we supplementally advise the Staff of certain background information relating to our relationship with
the partner referred to above (the “Partner”):
•
We originally entered into a license and supply agreement with the Partner in [***], under which we license certain of our intellectual property rights and agree to manufacture and supply a raw material
“reagent” used in the manufacturing of one of the Partner’s drug products. [***].
•
[***]. We were also contracted to receive a sales price for the supply of the reagent [***] and royalties based on sales of the drug product following commercialization.
•
[***]. We manufacture the reagent based on the binding purchase orders received from the Partner [***].
•
[***].
[***].
Also, as disclosed in our Form 10-K, in our Management’s Discussion and Analysis of Financial
Condition and Results of Operations, Overview-Strategic Direction of Our Business (pg 48): “Historically, we have entered into a number of license and supply contracts under which we manufactured and supplied our proprietary polymer reagents on
a fixed price or cost-plus basis. Our current strategy is to manufacture and supply polymer reagents to support our proprietary drug candidates or our third-party collaborators where we have a strategic development and commercialization relationship
or where we derive substantial economic benefit.” This manufacturing activity is not a core component of our business strategy. We have elected to only enter into and maintain those manufacturing relationships associated with long-term
collaboration agreements which include multiple sources of revenue, which we view holistically and in aggregate.
2
*** Information omitted and
provided under separate cover to the Staff pursuant to 17 C.F.R. §200.83
Accounting Analysis
In considering
ASC 330-10-35-1, we supplementally advise the Staff that, as noted above and disclosed in Note 1 to our Consolidated
Financial Statements as of and for the fiscal year ended December 31, 2016 included in the Form 10-K, we manufacture our inventory of the reagent based on the receipt of firm purchase orders from the
Partner. We analyze inventory impairment for the reagent based on the totality of our contractual relationship with the Partner. At each reporting period, we evaluate whether there is an inventory impairment caused by factors such as damage,
physical deterioration, obsolescence, or a decrease in the utility of our inventory. To date we have noted no general impairment factors associated with this reagent; however, from time to time we identify and record
lot-specific manufacturing reserves for lots that do not meet all required quality specifications.
In evaluating net realizable value of the inventory value on hand at each reporting period under ASC 330-10-35, we acknowledge that our gross margin is negative when including only the price paid per unit of the reagent shipped to the Partner. We note that
Subtopic 330-10 and the ASC Master Glossary do not provide guidance regarding the term “selling price” used in the definition “net realizable value.” [***], we believe the
consideration for the product sold to the Partner comprises both the fixed price per gram of the reagent and the [***] royalty revenue from the sales of the drug product. Accordingly, we have used this aggregated amount in our definition of net
realizable value.
[***].
When we include both the fixed sales price of the reagent and the [***] royalty revenue, our net realizable value is greater than the
inventory cost at the end of each reporting period. Accordingly, we concluded that our inventory valuation is not in excess of net realizable value and that we should not adjust the basis of inventory pursuant to ASC 330-10-35-1.
The table below summarizes the
product sales, [***] royalty revenue, cost of goods sold and gross margin related to the Partner for the periods of the fiscal year ended December 31, 2016 and the nine months ended September 30, 2017 (in thousands):
Year Ended
December 31,
2016
Nine months
ended September 30,
2017
Product sales
[***]
[***]
[***] royalty revenue
[***]
[***]
Total revenue from sales of product
[***]
[***]
Cost of goods sold
[***]
[***]
Gross margin
[***]
[***]
We also considered the guidance in ASC 330-10-35-2, which states:
“The cost basis of recording inventory
ordinarily achieves the objective of a proper matching of costs and revenues. However, under certain circumstances cost may not be the amount properly chargeable against the revenues of future periods.”
3
*** Information omitted and
provided under separate cover to the Staff pursuant to 17 C.F.R. §200.83
We had considered an alternative method, under which we would impair inventory in the periods of
production for the amount less than the fixed price. This would result in recording a portion of the inventory costs as a period cost over several periods, as the inventory is produced. Then, we would recognize product sales with no margin when the
reagent is sold. We concluded that such a method would reduce rather than improve the level of matching of revenues and expenses. It would also make it difficult for financial statement users to understand trends in costs incurred to manufacture
materials for our partners. We concluded that it would be more beneficial to recognize costs to produce the inventory when shipped to the Partner, which results in matching those costs with the fixed price component of the consideration.
* * * * *
The Company hereby acknowledges that:
•
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.
If you have additional questions, please do not hesitate to contact the undersigned at (415) 482-5570
or Jillian B. Thomsen, Senior Vice President, Finance and Chief Accounting Officer, at (415) 482-5555.
Sincerely,
/s/ Gil M. Labrucherie
Gil M. Labrucherie
Senior Vice President and Chief Financial Officer
cc:
Angela Connell, Accounting Branch Chief, Division of Corporation Finance
Jillian B. Thomsen, Senior Vice President, Finance and Chief Accounting Officer of Nektar
Therapeutics
Mark A. Wilson, Vice President and General Counsel of Nektar Therapeutics
Sam Zucker, Esq., Sidley Austin LLP
4
2017-11-15 - CORRESP - NEKTAR THERAPEUTICS
CORRESP 1 filename1.htm CORRESP Nektar Therapeutics 455 Mission Bay Boulevard South San Francisco, California 94158-2117 November 15, 2017 VIA EDGAR Office of Healthcare and Insurance United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Ibolya Ignat, Senior Staff Accountant Re: Nektar Therapeutics Form 10-K for the Fiscal Year Ended December 31, 2016 Filed March 1, 2017 File No. 000-24006 Dear Ms. Ignat: We are in receipt of the letter from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) dated November 1, 2017, regarding the Annual Report on Form 10-K for the fiscal year ended December 31, 2016 (File No. 000-24006) filed by Nektar Therapeutics, a Delaware corporation (the “Company”), on March 1, 2017. We hereby respectfully request that the Commission grant an extension of the deadline for the Company to provide its response to the Staff’s comment in the letter to November 24, 2017. If you have any questions regarding this request, please do not hesitate to contact the undersigned at (415) 482-5570. Sincerely, /s/ Gil M. Labrucherie Gil M. Labrucherie Senior Vice President and Chief Financial Officer cc: Angela Connell, Accounting Branch Chief, Division of Corporation Finance Jillian B. Thomsen, Senior Vice President, Finance and Chief Accounting Officer of Nektar Therapeutics Mark A. Wilson, Vice President and General Counsel of Nektar Therapeutics Sam Zucker, Esq., Sidley Austin LLP
2017-11-01 - UPLOAD - NEKTAR THERAPEUTICS
November 1, 2017
Gil M. Labrucherie
Senior Vice President and Chief Financial Officer
Nektar Therapeutics
455 Mission Bay Boulevard South
San Francisco, California 94158
Re:Nektar Therapeutics
Form 10-K for the Fiscal Year Ended December 31, 2016
Filed March 1, 2017
File No. 000-24006
Dear Mr. Labrucherie:
We have limited our review of your filing to the financial statements and related
disclosures and have the following comment. In our comment we may ask you to provide us
with information so we may better understand your disclosure.
Please respond to the comment within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe our
comment applies to your facts and circumstances, please tell us why in your response.
After reviewing your response to the comment, we may have additional comments.
Form 10-K for the Fiscal Year Ended December 31, 2016
Management’s Discussion and Analysis of Financial Condition and Results of Operations
Results of Operations
Cost of goods sold , page 50
1.You disclose that you have a manufacturing arrangement with a partner that includes a
fixed price which is less than the fully burdened manufacturing cost for the reagent and
that you expect this situation with this partner to continue in future years. Please tell us
how you determined whether an adjustment to the cost basis of your inventory was
warranted pursuant to ASC 330-10-35-1. Please also quantify for us the sales, cost of
good sold and gross profit for this product for your most recent annual and interim
periods.
FirstName LastNameGil M. Labrucherie
Comapany NameNektar Therapeutics
June 16, 2017 Page 2
FirstName LastName
Gil M. Labrucherie
Nektar Therapeutics
November 1, 2017
Page 2
In closing, we remind you that the company and its management are responsible for the
accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or
absence of action by the staff.
You may contact Ibolya Ignat, Senior Staff Accountant, at (202) 551-3636 or Angela
Connell, Accounting Branch Chief, at (202) 551-3426 with any questions.
Division of Corporation Finance
Office of Healthcare & Insurance
2011-08-26 - UPLOAD - NEKTAR THERAPEUTICS
August 26, 2011 Via E-mail John Nicholson Senior Vice President and Chief Financial Officer Nektar Therapeutics 455 Mission Bay Boulevard South San Francisco, CA 94158 Re: Nektar Therapeutics Form 10-K for the Fiscal Year Ended December 31, 2010 Filed March 1, 2011 File No. 000-24006 Dear Mr. Nicholson: We have completed our review of your f iling. We remind you that our comments or changes to disclosure in res ponse to our comments do not for eclose the Commission from taking any action with respect to the company or th e filing and the company may not assert staff comments as a defense in any proceeding ini tiated by the Commission or any person under the federal securities laws of the United States. We urge all pers ons who are responsible for the accuracy and adequacy of the disclosure in the fi ling to be certain that the filing includes the information the Securities Exchange Act of 1934 and all applicable rules require. Sincerely, /S/ Joel Parker Joel Parker Accounting Branch Chief
2011-08-11 - CORRESP - NEKTAR THERAPEUTICS
CORRESP
1
filename1.htm
Unassociated Document
Nektar Therapeutics
455 Mission Bay Boulevard South
San Francisco, CA 94158
August 11, 2011
VIA ELECTRONIC TRANSMISSION
Securities and Exchange Commission
Division of Corporation Finance
Washington, D.C. 20549
Attention: Jim B. Rosenberg, Senior Assistant Chief Accountant
Re:
Nektar Therapeutics -- Form 10-K for the Fiscal Year Ended December 31, 2010 (File No. 000-24006)
Dear Mr. Rosenberg:
We are in receipt of the letter from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) dated July 28, 2011, regarding the Form 10-K for the fiscal year ended December 31, 2010 (File No. 000-24006) filed by Nektar Therapeutics, a Delaware corporation (the “Registrant”), on March 1, 2011 (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.
Overview of Selected Nektar Proprietary Drug Development Programs and Significant Partnered Drug Development Programs, page 10
1.
With respect to your global license agreement with AstraZeneca AB, please disclose in future filings the aggregate development milestones that you are eligible to receive for NKTR-118 and NKTR-119.
Response:
Disclosure has been added on page 13 of the Registrant’s Form 10-Q for the fiscal quarter ended June 30, 2011, filed with the Commission on August 5, 2011, in response to the Staff’s comment.
Patents and Proprietary Rights, page 21
2.
We note that you are a party to a Cross-License and Option Agreement with Enzon Pharmaceuticals, Inc. whereby you are required to share future royalty payments for several of your products with Enzon. Please provide proposed disclosure to be included in future filings that discloses the range of royalties, within ten percent, that you are required to pay. An acceptable range of royalties is one of the following: “single-digits,” “teens,” “twenties,” etc. In addition, please file the agreement as an exhibit pursuant to Item 601(b)(1)(ii)(B) of Regulation S-K, or, alternatively, tell us the basis for your belief that you are not required to file the agreement.
Response:
In response to the Staff’s comment, we propose the following disclosure to be included in future filings.
“In January 2002, we entered into a Cross-License and Option Agreement with Enzon Pharmaceuticals, Inc., pursuant to which we and Enzon provided certain licenses to selected portions of each party’s patent portfolio. In certain cases, we have the option to license certain of Enzon’s patents for use in our proprietary products or to grant sublicenses to third parties, in each case in exchange for payments to Enzon based on manufacturing profits, revenue share or royalties on net sales if a designated product candidate is approved in one or more markets. Where we have opted to receive a license, or to sublicense Enzon patents to a third party, the potential payments to Enzon equate to low or mid single-digit royalties on net sales of the product by us or our sublicensee, depending on the categorization of the particular Nektar proprietary product or third party sublicensed product under the Cross-License and Option Agreement. Our payment obligations to Enzon terminate at various future dates based upon the expiration of the relevant valid patent claims in the Enzon patents that are licensed or sublicensed.”
The Registrant respectfully submits that the Cross-License and Option Agreement with Enzon Pharmaceuticals, Inc. is not material to the business of the Registrant and is not required to be filed as an exhibit pursuant to Item 601(b)(1)(ii)(B) of Regulation S-K. [***].
Management’s Discussion and Analysis of Financial Condition and Results of Operations Liquidity and Capital Resources
Cash flows from operating activities, page 55
3.
Your accounts receivables increased by $20.3 million between December 31, 2009 and December 31, 2010, and decreased by $22.9 million at March 31, 2011. We were unable to find a discussion of the reason or the source of the change in the amount. Please provide us proposed disclosure to be included in future filings that addresses the reasons for these changes and their effects on cash flows from operating activities.
Response:
Disclosure has been added on page 20 of the Registrant’s Form 10-Q for the fiscal quarter ended June 30, 2011, filed with the Commission on August 5, 2011, in response to the Staff’s comment.
Notes to Consolidated Financial Statements
Note 1 — Organization and Summary of Significant Accounting Policies
Revenue Recognition
Product sales and royalties, page 69
4.
You state that product sales revenues are recognized in accordance with the terms of the related agreement. Please provide us proposed disclosure to be included in future filings describing your revenue recognition policy for products sold under these agreements, as in accordance with the terms of the related agreement is vague.
Response:
Disclosure has been added on page 8 of the Registrant’s Form 10-Q for the fiscal quarter ended June 30, 2011, filed with the Commission on August 5, 2011, in response to the Staff’s comment.
* * *
As specifically requested by the Commission, the Registrant acknowledges that:
·
the Registrant 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 Registrant 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.
[Remainder of page intentionally left blank]
If you have any questions or require any additional information with respect to any of the matters discussed in this letter, please call the undersigned at (415) 482-5570.
Sincerely,
/s/ Gil M. Labrucherie
Gil M. Labrucherie
Senior Vice President, General Counsel & Secretary
cc:
Howard W. Robin, President and Chief Executive Officer of Nektar Therapeutics
John Nicholson, Senior Vice President and Chief Financial Officer of Nektar Therapeutics
Jill Thomsen, Senior Vice President, Finance and Chief Accounting Officer of Nektar Therapeutics
Sam Zucker, Esq., O’Melveny & Myers LLP
2011-07-28 - UPLOAD - NEKTAR THERAPEUTICS
July 28, 2011
Via E-mail
John Nicholson Senior Vice President and Chief Financial Officer
Nektar Therapeutics 455 Mission Bay Boulevard South San Francisco, CA 94158
Re: Nektar Therapeutics Form 10-K for the Fiscal Year Ended December 31, 2010
Filed March 1, 2011 File No. 000-24006
Dear Mr. Nicholson:
We have limited our review of your filing to those issues we have addressed in our
comments. In our comments, we ask you to pr ovide us with information so we may better
understand your disclosure.
Please respond to this letter within te n business days by providing the requested
information or by advising us when you will provide the requested response. If you do not
believe a comment applies to your facts and circ umstances, please tell us why in your response.
Please furnish us a letter on EDGAR under the fo rm type label CORRESP that keys your
responses to our comments.
After reviewing the information you provide in response to these comments, we may
have additional comments and/or request that you amend your filing. Overview of Selected Nektar Proprietary Drug Development Progr ams and Significant Partnered
Drug Development Programs, page 10
1. With respect to your global license agreement w ith AstraZeneca AB, please disclose in future
filings the aggregate developm ent milestones that you are elig ible to receive for NKTR-118
and NKTR-119.
Patents and Proprietary Rights, page 21
2. We note that you are a party to a Cross- License and Option Agreement with Enzon
Pharmaceuticals, Inc. whereby you are required to share future royalty payments for several
of your products with Enzon. Please provide pro posed disclosure to be included in future
filings that discloses the range of royalties, within ten percen t, that you are required to pay.
An acceptable range of royalties is one of the fo llowing: “single-digits,” “teens,” “twenties,”
John Nicholson
Nektar Therapeutics July 28, 2011 Page 2
etc. In addition, please file the agreement as an exhibit pursuant to Item 601(b)(10)(ii)(B) of
Regulation S-K, or, alternatively, tell us the basis for your belief that you are not required to
file the agreement.
Management’s Discussion and Analysis of Fi nancial Condition and Results of Operations
Liquidity and Capital Resources
Cash flows from operating activities, page 55
3. Your accounts receivables increased by $20.3 million between December 31, 2009 and
December 31, 2010, and decreased by $22.9 milli on at March 31, 2011. We were unable to
find a discussion of the reason or the source of the change in the amount. Please provide us
proposed disclosure to be included in future filings that addresses the reasons for these
changes and their effects on cash fl ows from operating activities.
Notes to Consolidated Financial Statements
Note 1 — Organization and Summary of Significant Accounting Policies
Revenue Recognition
Product sales and royalties, page 69
4. You state that product sales revenues are recognized in ac cordance with the terms of the
related agreement. Please provide us proposed di sclosure to be includ ed in future filings
describing your revenue recogni tion policy for products sold unde r these agreements, as in
accordance with the terms of the related agreement is vague.
We urge all persons who are responsible for th e accuracy and adequacy of the disclosure
in the filing to be certain that the filing include s the information the Securities Exchange Act of
1934 and all applicable Exchange Act rules requir e. Since the company and its management are
in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy
and adequacy of the disclosures they have made.
In responding to our comments, please provi de a written statement from the company
acknowledging that:
the company is responsible for the adequacy an d accuracy of the disclo sure 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 federa l securities laws of the United States.
John Nicholson
Nektar Therapeutics July 28, 2011 Page 3
You may contact Tabatha Akin s, Staff Accountant, at ( 202) 551-3658 or Joel Parker,
Accounting Branch Chief, at (202) 551-3651 if you have any questions regarding the processing
of your response as well as any questions rega rding comments on the financial statements and
related matters. Please cont act Johnny Gharib, Attorney Advi sor, at (202) 551-3170 or Dan
Greenspan, Legal Branch Chief at (202) 551-3623 with questions on other comments. In this
regard, do not hesitate to c ontact me at (202) 551-3679.
Sincerely,
/s/ Jim B. Rosenberg
Jim B. Rosenberg
Senior Assistant Chief Accountant
2009-02-23 - UPLOAD - NEKTAR THERAPEUTICS
Via Facsimile and U.S. Mail Mail Stop 6010 February 23, 2009 Mr. Gil M. Labrucherie Senior Vice President, Gene ral Counsel and Secretary
Nektar Therapeutics 201 Industrial Road San Carlos, CA 94070
Re: Nektar Therapeutics
Form 10-K for the Year Ended December 31, 2007 Filed February 29, 2008 File No. 000-24006
Dear Mr. Labrucherie: We have completed our review of your annual report on Form 10-K and have no
further comments at this time.
Sincerely,
J e f f r e y P . R i e d l e r A s s i s t a n t D i r e c t o r
2009-02-19 - CORRESP - NEKTAR THERAPEUTICS
CORRESP
1
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Nektar
Therapeutics
201
Industrial Road
San
Carlos, California 94070
Sender
Contact Information
P: (650)
620-5990
F: (650)
620-5360
February
19, 2009
VIA ELECTRONIC
TRANSMISSION
Securities
and Exchange Commission
Division
of Corporation 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 February 13, 2009, including comments from the staff
(the “Staff”) of the
Securities and Exchange Commission (the “Commission”) related to the
letter from the Staff dated December 10, 2008 regarding 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.
Item
1. Business
Patents and Proprietary
Rights, page 17
1.
We note your response to
comment 4 of our comment letter dated December 10, 2008 and your proposal
to include disclosure regarding the acquisition of Shearwater Corporation,
which led to your entry into the PEGylation business in your 2008 Form
10-K. Please advise us as to whether Shearwater Corporation was
the licensee of technology and intellectual property that was assigned to
you as a result of the acquisition or whether you acquired in-house,
proprietary technology and intellectual property directly from Shearwater
Corporation as a result of the acquisition. If the relevant
technology and intellectual property was acquired subject to a license
agreement, please include the material terms of the license in your
disclosure, including exclusivity provisions, geographic limitations and
term and termination provisions and file any such license as an exhibit to
your 2008 Form 10-K or provided as with a detailed analysis supporting
your determination that such technology and intellectual property are not
material to your business.
Response:
The
acquisition of Shearwater Corporation primarily involved the acquisition of
proprietary intellectual property and scientific personnel. The
section titled “Patents and Proprietary Rights” in the Registrant’s Form 10-K
for the fiscal year ended December 31, 2001, filed by the Registrant on April 1,
2002, discusses some of the intellectual property involved in the
acquisition. The only patent license agreement to Shearwater
Corporation at the time of the acquisition by the Registrant was that certain
License Agreement dated as of June 17, 1993, by and between the University of
Alabama in Huntsville (“UAH”) and Shearwater Polymers,
Inc. (the “Original UAH
License”), which agreement granted a license to the subject matter of a
UAH patent (the “UAH
Patent”). The Original UAH License was terminated in its
entirety by that certain Settlement Agreement and General Release dated as of
June 30, 2006, by and between the Board of Trustees of UAH and UAH, on the one
hand, and Nektar Therapeutics AL, Corporation, Nektar Therapeutics and J. Milton
Harris, on the other hand (the “UAH Settlement
Agreement”). The UAH Settlement Agreement granted a new
license to the subject matter of the UAH Patent. The UAH Settlement
Agreement was originally filed by the Registrant as an exhibit to a Form 8-K
dated July 7, 2006 and was filed with the Form 10-K pursuant to a determination
by the Registrant that the UAH Settlement Agreement constituted a material
agreement due to the settlement amount and not because the license granted to
the Registrant under the UAH Settlement Agreement was material to the business
of the Registrant. The Registrant will continue to file the UAH
Settlement Agreement with the Form 10-K for the fiscal year ended December 31,
2008. The Registrant does not believe that the license to the UAH
Patent granted to the Registrant under the UAH Settlement Agreement is material
to its business since the UAH Patent covered by the license is not relevant to
any of the Registrant’s proprietary drug candidates or intellectual property
licensed to third party collaborators.
* * *
As
specifically requested by the Commission, the Registrant acknowledges
that:
·
the
Registrant 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
Registrant 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.
2
If you
have any questions or require any additional information with respect to any of
the matters discussed in this letter, please call the undersigned at (650)
620-5990 or Jennifer A. DePalma, Esq. at (650) 473-2670.
Sincerely,
/s/ Gil
M. Labrucherie
Gil
M. Labrucherie
Senior
Vice President, General Counsel & Secretary of Nektar
Therapeutics
cc:
Howard
W. Robin, President and Chief Executive Officer of Nektar
Therapeutics
Sam
Zucker, Esq., O’Melveny & Myers
LLP
Jennifer
A. DePalma, Esq., O’Melveny & Myers
LLP
3
2009-02-13 - UPLOAD - NEKTAR THERAPEUTICS
Via Facsimile and U.S. Mail Mail Stop 6010 February 13, 2009 Mr. Howard W. Robin President and Chief Executive Officer Nektar Therapeutics 201 Industrial Road San Carlos, CA 94070 Re: Nektar Therapeutics Form 10-K for the Year Ended December 31, 2007 Filed February 29, 2008 File No. 000-24006 Dear Mr. Robin: We have reviewed your filing and have the following comment. In our comment, we ask you to provide us with information to better understand your disclosure. After reviewing the information provided, we may raise additional comments and/or request that you amend your filing. Please understand that the purpose of our re view 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 comment or on any other aspect of our review. Feel free to call us at the telephone numbers listed at the end of this letter. Item 1. Business Patents and Proprietary Rights, page 17 1. We note your response to comment 4 of our comment letter dated December 10, 2008 and your proposal to include disclo sure regarding the acquisition of Shearwater Corporation, which led to your entry into the PEGylation business in your 2008 Form 10-K. Please advise as to whether Shearwater Corporation was the licensee of technology a nd intellectual property that was assigned to you as a result of the acquisition or whether y ou acquired in-house, proprietary technology and intellectual propert y directly from Shearwater Cor poration as a result of the acquisition. If the releva nt technology and intellectual property was acquired subject to a license agreement, please include the material terms of the license in Mr. Howard W. Robin Nektar Therapeutics February 13, 2009 Page 2 your disclosure, including exclusivity pr ovisions, geographic limitations and term and termination provisions and file any such license as an exhibit to your 2008 Form 10-K or provided as with a detaile d analysis supporting your determination that such technology and inte llectual property are not mate rial to your business. * * * * Please respond to this comment within 10 business days or tell us when you will provide us with a response. Please furnish a cover letter th at keys your response to our comment and provide any requested information. Detailed letters gr eatly facilitate our review. Please file your letter on E DGAR under the form type label CORRESP. We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes all in formation required under the Securities Exchange Act of 1934 and th at they have provided all information investors require for an informed invest ment decision. Since the company and its management are in possession of all facts re lating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. In connection with responding to our co mments, please provide, in your letter, a statement from the company acknowledging that: • 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 comme nts as a defense in any proceeding initiated by the Commission or any person under the federal secu rities laws of the United States. In addition, please be advise d that the Division of Enfo rcement has access to all information you provide to the staff of the Divi sion of Corporation Fi nance in our review of your filing or in response to our comment on your filing. Please contact Nandini Acharya, Staff Atto rney at (202) 551-3495 or me at (202) 551-3715 with any questions. Sincerely, Jeffrey P. Riedler Assistant Director
2009-01-26 - CORRESP - NEKTAR THERAPEUTICS
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
2009-01-14 - CORRESP - NEKTAR THERAPEUTICS
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
14, 2009
VIA FACSIMILE AND U.S.
MAIL
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:
This
request is in relation to the letter dated December 10, 2008 (the “Comment Letter”), including
comments from the staff of the Securities and Exchange Commission to the Form
10-K for the year ended December 31, 2007 (File No. 000-24006) filed by Nektar
Therapeutics, a Delaware corporation, on February 29, 2008.
We
respectfully request an extension to January 23, 2009 to provide a response to
the Comment Letter.
Please do
not hesitate to call the undersigned at (650) 620-5990 or Jennifer A. DePalma,
Esq. of O’Melveny & Myers LLP, legal counsel to Nektar Therapeutics, at
(650) 473-2670, regarding this matter.
Sincerely,
/s/
Gil M. Labrucherie
Gil
M. Labrucherie
Senior
Vice President, General Counsel &
Secretary
of Nektar
Therapeutics
cc:
Howard
W. Robin, President and Chief Executive Officer of Nektar
Therapeutics
Sam
Zucker, Esq., O’Melveny & Myers LLP
Jennifer
A. DePalma, Esq., O’Melveny & Myers
LLP
2008-12-18 - CORRESP - NEKTAR THERAPEUTICS
CORRESP
1
filename1.htm
Nektar
Therapeutics
201
Industrial Road
San
Carlos, California 94070
Sender
Contact Information
P: (650)
620-5990
F: (650)
620-5360
December
18, 2008
VIA FACSIMILE AND U.S.
MAIL
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 of the Securities and Exchange Commission to the Form
10-K for the year ended December 31, 2007 (File No. 000-24006) filed by Nektar
Therapeutics, a Delaware corporation, on February 29, 2008.
We will
provide a response to the Comment Letter no later than January 16,
2009.
Please do
not hesitate to call the undersigned at (650) 620-5990 or Jennifer A. DePalma,
Esq. of O’Melveny & Myers LLP, legal counsel to Nektar Therapeutics, at
(650) 473-2670, regarding this matter.
Sincerely,
/s/
Gil M. Labrucherie
Gil
M. Labrucherie
Senior
Vice President, General Counsel & Secretary of Nektar
Therapeutics
cc:
Howard
W. Robin, President and Chief Executive Officer of Nektar
Therapeutics
Sam
Zucker, Esq., O’Melveny & Myers
LLP
Jennifer
A. DePalma, Esq., O’Melveny & Myers
LLP
2008-12-10 - UPLOAD - NEKTAR THERAPEUTICS
Via Facsimile and U.S. Mail Mail Stop 6010 December 10, 2008 Mr. Howard W. Robin President and Chief Executive Officer Nektar Therapeutics 201 Industrial Road San Carlos, CA 94070 Re: Nektar Therapeutics Form 10-K for the Year Ended December 31, 2007 Filed February 29, 2008 File No. 000-24006 Dear Mr. Robin: We have reviewed your filing and have the following comments. Where indicated, we think you should revise your Form 10-K in response to this comment. If you disagree, we will consider your explanation as to why our comment is inapplicable or a revision is unnecessary. In our comment, we ask you to provide us with information so we may better understand your disclosure. After reviewing this information, we may raise additional comments. Please understand that the purpose of our re view 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 comment or on any other aspect of our review. Feel free to call us at the telephone numbers listed at the end of this letter. 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 descripti on of each of the following agreements, including the material terms of each agr eement, the aggregate potential milestone payments, the aggregate royalty and milest one amounts received or paid to date and the term and termination provisions. If any of the agreements terminate upon Mr. Howard W. Robin Nektar Therapeutics December 10, 2008 Page 2 the last-to-expire relevant patent, please disclose the year of expiration of such patent. Item 601(b) (10) of Regulation S-K require s you to include material contracts as exhibits. Pleas e file each agreement as an exhibit to the Form 10-K or provide us with a comprehensive anal ysis supporting your determination that these agreements are not ma terial 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. Item 1. Business, pages 9-12 2. We note your description of selected collaborative agreements under which you may receive milestone payments. Please revise the discussion of these agreements to include a description of the material terms of each agreement, including the aggregate potential milest one payments and the aggregate amounts of milestone payments and royalties r eceived to date. Additionally, please describe the term and termination provisions . If any of the agreements terminate upon the last-to-expire relevant patent, plea se disclose the year of expiration of such patent. 3. We note that several of the selected colla borative agreements described in this section have not been filed as exhibits to your Form 10-K. Please include the following agreements as exhibits to the Fo rm 10-K or provide us with an analysis supporting your determination that these agreements are not material to your business: • Collaborative Research, Development and Commercialization agreement with Novartis Pharma AG; • 2005 Collaboration Agreement with Bayer AG to develop an inhaled powder formulation of a novel form of Ciprofloxacin; Mr. Howard W. Robin Nektar Therapeutics December 10, 2008 Page 3 • License, Manufacturing and Supply Agreement for CIMZIA™ with UCB Pharma; and • License, Manufacturing and Supply Agreement for the license of your proprietary PEGylation reagent with Hoffman-La Roche Ltd. Patents and Proprietary Rights, page 17 4. Please expand your disclosure in this s ection to address whether you developed your PEGylation and pulmonary technology and related intellectual property internally or whether you acquired such technology and related intellectual property. If any of your key technology and intellectual property was acquired, please identify the party from which it was acquired and the material terms of the license, including exclusivity provisions, geographic limitations, and term and termination provisions. Please file any such license as an exhibit. * * * * Please amend your Form 10-K and respond to these comments within 10 business days or tell us when you will provide us with a response. Please furnish a cover letter with your amendment that keys your response to our comment and provide any requested information. Detailed letters greatly facilitate our review. Please file your letter on EDGAR under the form type label CORRESP. We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes all in formation required under the Securities Exchange Act of 1934 and th at they have provided all information investors require for an informed invest ment decision. Since the company and its management are in possession of all facts re lating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. In connection with responding to our co mments, please provide, in your letter, a statement from the company acknowledging that: • 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 comme nts as a defense in any proceeding initiated by the Commission or any person under the federal secu rities laws of the United States. Mr. Howard W. Robin Nektar Therapeutics December 10, 2008 Page 4 In addition, please be advise d that the Division of Enfo rcement has access to all information you provide to the staff of the Divi sion of Corporation Fi nance in our review of your filing or in response to our comment on your filing. Please contact Nandini Acharya, Staff Atto rney at (202) 551-3495 or me at (202) 551-3715 with any questions. Sincerely, Jeffrey P. Riedler Assistant Director