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SEC Company Response from PROTHENA CORP PUBLIC LTD (PRTA) — Jun 26, 2019

PROTHENA CORP PUBLIC LTD CO
Date: June 26, 2019 · CIK: 0001559053 · Accession: 0001193125-19-181756

AI Filing Summary & Sentiment

File numbers found in text: 001-35676

Referenced dates: May 29, 2019

Date
June 26, 2019
Author
Not clearly detected
Form
CORRESP
Company
PROTHENA CORP PUBLIC LTD CO

Letter

FOIA CONFIDENTIAL TREATMENT REQUESTED PURSUANT TO RULE 83

Prothena Corporation plc

77 Sir John Rogerson’s Quay, Block C

Grand Canal Docklands

Dublin 2, D02 T804, Ireland

June 26, 2019

Via EDGAR Transmission and Overnight Delivery

U.S. Securities and Exchange Commission

Division of Corporation Finance

Office of Healthcare & Insurance

100 F Street, N.E.

Washington, DC 20549

Attention:

Frank Wyman

Tabatha McCullom

Re:

Prothena Corporation plc

Form 10-K for the Fiscal Year Ended December 31, 2017

Filed February 26, 2018

Form 10-Q for the Quarterly Period Ended September 30, 2018

Filed November 6, 2018

File No. 001-35676

Ladies and Gentlemen:

Prothena Corporation plc (the “Company” or “Prothena”) submits this letter in response to further comments received by letter dated May 29, 2019 from the Staff of the Securities and Exchange Commission (the “Staff”). A courtesy copy of this letter is being submitted to the Staff by overnight delivery.

Each of the Staff’s comments is reproduced below in bold. The Company’s response follows each such Staff comment. Capitalized terms used but not defined herein have the meanings ascribed to them in the Master Collaboration Agreement by and between Prothena Biosciences Limited (“Prothena”) and Celgene Switzerland LLC (“Celgene”) dated March 20, 2018 (the “Agreement”) to which the Staff’s comments relate.

Form 10-Q for the Quarterly Period Ended September 30, 2018

Item 1. Financial Statements (unaudited)

Notes to the Condensed Consolidated Financial Statements

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested by Prothena Corporation plc with respect to portions of this letter.

Confidential Treatment Requested by Prothena Corporation plc

PRTA-1

8. Significant Agreements

Celgene Collaboration Agreement, page 18

1. It appears that your response may not have fully addressed prior comment 4 in two ways. First, that comment asked if your disclosure had an inconsistency because your disclosure states that a material right exists, but it also states there is no performance obligation at the inception of the contract. Because ASC 606-10-55-42 states that a material right is a performance obligation those statements appear to be in conflict. For clarity, we confirm that our comment relates to the material right, not the goods or services that Celgene can purchase by exercising the option. Second, it is not clear from that response and your disclosure how many material rights exist. Please provide additional explanation and propose revisions to your disclosure to clarify.

Company Response:

Under ASC 606-10-55-42, an option to acquire additional goods and services gives rise to a performance obligation if the option provides a material right to the customer that it would not receive without entering into that contract. If the option provides a material right to the customer, the customer in effect pays the entity in advance for future goods or services, and the entity recognizes revenue when those future goods or services are transferred or when the option expires.

The material right is the performance obligation, not the goods or services that the customer can purchase by exercising the option.

The FASB-IASB Joint Transition Resource Group for Revenue Recognition agreed that an entity would not account for the goods or services underlying a customer option as a performance obligation because the entity does not have any enforceable rights regarding those goods or services (see TRG 11-15.48).

Under the Agreement, there are a total of six independently exercisable options including the US Right and the Global Right to acquire a US License and a Global License, respectively, and rights to certain development services (following exercise of the US Right and the Global Right) for each of the three programs. Under ASC 606, these options are material rights and, therefore, are performance obligations. For each program, Celgene can exercise the US Right without exercising the Global Right; however, exercise of the Global Right is dependent on prior exercise of the US Right for that program. Nonetheless, a separate purchasing decision must be made for each of these options and they convey licenses with different attributes upon exercise (i.e., as to geography and program). Therefore, the Company believes each option should therefore be accounted for separately in a similar manner as illustrated in Example 61B of ASC 606 and that they should not be combined.

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested by Prothena Corporation plc with respect to portions of this letter.

Confidential Treatment Requested by Prothena Corporation plc

PRTA-2

To clarify disclosures in its future filings, the Company plans to revise descriptions in the notes to its consolidated financial statements (bolded and underlined language are additions to the previous disclosure) as shown in Exhibit A attached to this letter.

2. As a follow-up to prior comment 2, please reconcile for us the transaction economics to your assertion that there are no implied promises for you to provide research and development services or to use best efforts to file an IND. For example, it appears that Celgene has no ability to realize the value of its nonrefundable $110 million upfront payment absent further research and development, which it appears Celgene is prohibited from performing or directing prior to the exercise of its options, which cannot occur until you file an IND.

Company Response:

The Company respectfully advises the Staff that, as the Company stated in its February 29, 2019 response, at a fundamental level, the transaction reflected in the Agreement are options – secured by a nonrefundable upfront payment (of $100 million and $10.2 million premium on the ordinary shares purchased under the SSA) – granted to Celgene to acquire at a future date certain license rights to specified potential therapeutics programs that Prothena might further develop. Prothena is not obligated, and has not agreed to undertake research or development of any of those programs, but to the extent it does, Celgene has positioned itself on an exclusive basis – by making the $100 million upfront payment – to exercise options for US and then global licenses for the agreed upon exercise prices.

Celgene made the nonrefundable upfront payment to receive the option to potentially monetize programs which the Company believes may have considerable upside. However, if Prothena chooses not to pursue R&D activities or file an IND for the three potential programs, Celgene will not receive any goods or services from its upfront payment.

Another way to say this is that Celgene does not obtain control over any distinct goods or services unless and until it exercises one or more of its options. While Prothena may or may not conduct R&D activities on these programs, unless and until Celgene exercises an option, Celgene does not obtain control of the results of that R&D effort. Therefore, consistent with the response to Comment Number One above, while the Company does have a performance obligation (and therefore a liability under ASC 606), it is not an obligation to perform R&D activities but a material right to licenses if and when the options are exercised.

As a material right in accordance with ASC 606-10-55-46, the contract liability to which these material rights relate will only be derecognized when either the options expire or are exercised (and control of the underlying goods and services transferred). The Company believes it would be highly unusual and inconsistent with practice to allocate transaction price to an implied performance obligation for activities undertaken by an entity to provide access to an asset for evaluation purposes or to maintain or enhance an asset that is the

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested by Prothena Corporation plc with respect to portions of this letter.

Confidential Treatment Requested by Prothena Corporation plc

PRTA-3

subject of an option, even when that option represents a material right. By way of comparison, the Company believes up-front payments to secure material rights to acquire commercial or developable property are common in the real estate industry. The Company does not believe the grantors of those material rights in their accounting analysis for those contracts are also concluding that they have performance obligations to provide access to the property for evaluation purposes or for activities they would otherwise undertake as the owner of the property to maintain and repair the property or enhance its value by, for instance, obtaining tenants before the option is exercised or expires. The Company believes a similar line of reasoning should be applied to our arrangement with Celgene.

Typically, implied promises for services that constitute performance obligations relate to assets that a customer already controls, such as extended warranties for physical products or post-contract customer support (PCS) for licensed software, and cannot relate to assets that the customer does not control or only may control in the future. While the Company may or may not conduct R&D activities on these programs, unless and until Celgene exercises one or more of its option, Celgene does not obtain control of any aspect of that R&D effort. While the Company believes there is no implied promise here and certainly not one that is a performance obligation, the Company also considered that if there were an implied promise it would neither be capable of being distinct nor distinct in the context of the contract. Because any R&D services performed by the Company would not convey control over the results of that R&D unless and until the related option is exercised because the R&D relates only to the value of the underlying license which can only be captured by the customer in the event the option to such license is exercised. Therefore, the Company believes any such implied R&D promise would need to be combined with the option to acquire a license. Because the R&D services do not convey control of a valuable asset by themselves and revenue attributable to the option to acquire a license to the underlying technology does not qualify for over time recognition, the Company believes the combined unit of account would not be recognized as revenue until control of the underlying license was conveyed or the option to purchase the license expired.

The Company believes this also is consistent with the transaction economics. [***] Celgene does not obtain control over the underlying assets unless and until it commits substantial additional funds by exercising the option. That is, the customer is willing to pay a relatively small fee now for potential access to a much more valuable program further into development. ASC 606 is clear that payments associated with options cannot be recognized as revenue until the option is exercised (and the underlying goods or services delivered) or the right expires.

3. In your February 28, 2019 response, as part of your analysis of ASC 606 step 2, you identify a number of “Prothena Obligation(s)” and conclude they are not distinct performance obligations. Because a performance obligation consists of a distinct good or service or a bundle of goods and services that are distinct, it is not clear whether you are asserting that the items listed as “Prothena Obligation(s)” are not promised goods and services

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested by Prothena Corporation plc with respect to portions of this letter.

Confidential Treatment Requested by Prothena Corporation plc

PRTA-4

Company Response:

The Company respectfully submits to the Staff the following analysis by the Company of the Agreement at contract inception in response to Comment Number Three:

Contractual Provision

Promise

Performance Obligation

Distinct

Material

Participation on JSC

Yes1

Yes1

NA1

No1

US Right/IND Option to obtain underlying US License and ancillary services

Yes

Yes2

Yes

Yes2 –

Material

right

Global Right/Phase 1 Option to obtain underlying Global License and ancillary services

Yes

Yes2

Yes

Yes2 –

Material

right

Limited Licenses

Yes

No

No3

No

US and Global License

No4

No2

NA7

NA

Development services subsequent to US Right/IND Option Exercise

No4,8

No2,8

NA7

NA

Development services subsequent to Global Right/

Phase 1 Option Exercise

No4,9

No2,9

NA7

NA

Delivery of manufactured compound

No4

No5

NA7

NA

Prosecution, maintenance and enforcement of patents

No6

No6

NA7

NA

Ancillary support including technology transfer

No4

No10

NA7

NA

The Company determined that its participation on the joint steering committee and its subcommittees (collectively, the “JSC”) represents a performance obligation; however, it is quantitatively and qualitatively immaterial in the context of the Agreement. Per ASC 606, an entity is not required to assess whether promised goods or services are distinct if they are immaterial. The JSC has limited governance responsibilities and essentially serves as a mechanism for the Company to communicate and discuss with Celgene any research activities that the Company decides, at its sole discretion, to undertake. Additionally, the Company’s responsibilities vis-à-vis the JSC operate only to ensure that Celgene remains informed and are substantively limited to making decisions regarding the research activities which the Company chooses to undertake at its sole discretion.

An entity only accounts for a customer option when it conveys a material right to the customer that it would not receive without entering into the contract. Because Celgene has the option to acquire additional goods and services at a discount to the standalone selling price for those goods and services and Celgene would not be able to obtain these services without entering into the contract, the options are deemed material rights. The material right is the performance obligation (US Right and Global Right), not the goods or services (US License and Global License and development services post-option exercise) that the customer can purchase by exercising the option.

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested by Prothena Corporation plc with respect to portions of this letter.

Confidential Treatment Requested by Prothena Corporation plc

PRTA-5

The limited licenses under Sections 7.1.1 and 7.1.2 of the Agreement (the “Limited Licenses”) are not distinct because Celgene cannot benefit from the licenses on its own in a way that generates economic benefits.

Promise is contingent upon option exercise.

Inventory supply to the extent requested by Celgene to be paid to Prothena by Celgene at a reasonable stand-alone selling price for such supply. Given that (i) there is substantial uncertainty about the development of the programs, (ii) the pricing for the inventory is at its standalone selling price, and (iii) the manufacturing services require the entity to transfer additional goods or services that are incremental to the goods and services provided prior to the resolution of the contingency, there is no material right. Therefore, the Company’s supply of product is not considered a performance obligation unless and until, requested by Celgene.

Show Raw Text
CORRESP
1
filename1.htm

CORRESP

 FOIA CONFIDENTIAL TREATMENT REQUESTED PURSUANT TO RULE 83

Prothena Corporation plc

 77 Sir
John Rogerson’s Quay, Block C

 Grand Canal Docklands

Dublin 2, D02 T804, Ireland

 June 26, 2019

 Via EDGAR Transmission and Overnight Delivery

 U.S.
Securities and Exchange Commission

 Division of Corporation Finance

Office of Healthcare & Insurance

 100 F Street, N.E.

 Washington, DC 20549

Attention:

Frank Wyman

Tabatha McCullom

Re:

Prothena Corporation plc

Form 10-K for the Fiscal Year Ended December 31, 2017

Filed February 26, 2018

Form 10-Q for the Quarterly Period Ended September 30, 2018

Filed November 6, 2018

File No. 001-35676

 Ladies and Gentlemen:

 Prothena
Corporation plc (the “Company” or “Prothena”) submits this letter in response to further comments received by letter dated May 29, 2019 from the Staff of the Securities and Exchange Commission (the “Staff”). A
courtesy copy of this letter is being submitted to the Staff by overnight delivery.

 Each of the Staff’s comments is reproduced below in bold. The
Company’s response follows each such Staff comment. Capitalized terms used but not defined herein have the meanings ascribed to them in the Master Collaboration Agreement by and between Prothena Biosciences Limited (“Prothena”) and
Celgene Switzerland LLC (“Celgene”) dated March 20, 2018 (the “Agreement”) to which the Staff’s comments relate.

 Form
10-Q for the Quarterly Period Ended September 30, 2018

 Item 1. Financial Statements (unaudited)

Notes to the Condensed Consolidated Financial Statements

 [***] Certain information in this
document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested by Prothena Corporation plc with respect to portions of this letter.

Confidential Treatment Requested by Prothena Corporation plc

PRTA-1

 8. Significant Agreements

Celgene Collaboration Agreement, page 18

1.
 It appears that your response may not have fully addressed prior comment 4 in two ways. First, that comment
asked if your disclosure had an inconsistency because your disclosure states that a material right exists, but it also states there is no performance obligation at the inception of the contract. Because ASC 606-10-55-42 states that a material right
is a performance obligation those statements appear to be in conflict. For clarity, we confirm that our comment relates to the material right, not the goods or services that Celgene can purchase by exercising the option. Second, it is not clear from
that response and your disclosure how many material rights exist. Please provide additional explanation and propose revisions to your disclosure to clarify.

Company Response:

 Under
ASC 606-10-55-42, an option to acquire additional goods and services gives rise to a performance obligation if the option provides a material right to the customer that it would not receive without entering into that contract. If the option provides
a material right to the customer, the customer in effect pays the entity in advance for future goods or services, and the entity recognizes revenue when those future goods or services are transferred or when the option expires.

The material right is the performance obligation, not the goods or services that the customer can purchase by exercising the option.

The FASB-IASB Joint Transition Resource Group for Revenue Recognition agreed that an entity would not account for the goods or services
underlying a customer option as a performance obligation because the entity does not have any enforceable rights regarding those goods or services (see TRG 11-15.48).

Under the Agreement, there are a total of six independently exercisable options including the US Right and the Global Right to acquire a US
License and a Global License, respectively, and rights to certain development services (following exercise of the US Right and the Global Right) for each of the three programs. Under ASC 606, these options are material rights and, therefore, are
performance obligations. For each program, Celgene can exercise the US Right without exercising the Global Right; however, exercise of the Global Right is dependent on prior exercise of the US Right for that program. Nonetheless, a separate
purchasing decision must be made for each of these options and they convey licenses with different attributes upon exercise (i.e., as to geography and program). Therefore, the Company believes each option should therefore be accounted for separately
in a similar manner as illustrated in Example 61B of ASC 606 and that they should not be combined.

 [***] Certain information in this
document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested by Prothena Corporation plc with respect to portions of this letter.

Confidential Treatment Requested by Prothena Corporation plc

PRTA-2

 To clarify disclosures in its future filings, the Company plans to revise descriptions in
the notes to its consolidated financial statements (bolded and underlined language are additions to the previous disclosure) as shown in Exhibit A attached to this letter.

2.
 As a follow-up to prior comment 2, please reconcile for us the transaction economics to your assertion that
there are no implied promises for you to provide research and development services or to use best efforts to file an IND. For example, it appears that Celgene has no ability to realize the value of its nonrefundable $110 million upfront payment
absent further research and development, which it appears Celgene is prohibited from performing or directing prior to the exercise of its options, which cannot occur until you file an IND.

Company Response:

 The
Company respectfully advises the Staff that, as the Company stated in its February 29, 2019 response, at a fundamental level, the transaction reflected in the Agreement are options – secured by a nonrefundable upfront payment (of $100
million and $10.2 million premium on the ordinary shares purchased under the SSA) – granted to Celgene to acquire at a future date certain license rights to specified potential therapeutics programs that Prothena might further develop. Prothena
is not obligated, and has not agreed to undertake research or development of any of those programs, but to the extent it does, Celgene has positioned itself on an exclusive basis – by making the $100 million upfront payment – to exercise
options for US and then global licenses for the agreed upon exercise prices.

 Celgene made the nonrefundable upfront payment to receive the
option to potentially monetize programs which the Company believes may have considerable upside. However, if Prothena chooses not to pursue R&D activities or file an IND for the three potential programs, Celgene will not receive any goods or
services from its upfront payment.

 Another way to say this is that Celgene does not obtain control over any distinct goods or services
unless and until it exercises one or more of its options. While Prothena may or may not conduct R&D activities on these programs, unless and until Celgene exercises an option, Celgene does not obtain control of the results of that R&D
effort. Therefore, consistent with the response to Comment Number One above, while the Company does have a performance obligation (and therefore a liability under ASC 606), it is not an obligation to perform R&D activities but a material right
to licenses if and when the options are exercised.

 As a material right in accordance with ASC 606-10-55-46, the contract liability to
which these material rights relate will only be derecognized when either the options expire or are exercised (and control of the underlying goods and services transferred). The Company believes it would be highly unusual and inconsistent with
practice to allocate transaction price to an implied performance obligation for activities undertaken by an entity to provide access to an asset for evaluation purposes or to maintain or enhance an asset that is the

 [***] Certain information in this
document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested by Prothena Corporation plc with respect to portions of this letter.

Confidential Treatment Requested by Prothena Corporation plc

PRTA-3

subject of an option, even when that option represents a material right. By way of comparison, the Company believes up-front payments to secure material rights to acquire commercial or
developable property are common in the real estate industry. The Company does not believe the grantors of those material rights in their accounting analysis for those contracts are also concluding that they have performance obligations to provide
access to the property for evaluation purposes or for activities they would otherwise undertake as the owner of the property to maintain and repair the property or enhance its value by, for instance, obtaining tenants before the option is exercised
or expires. The Company believes a similar line of reasoning should be applied to our arrangement with Celgene.

 Typically, implied
promises for services that constitute performance obligations relate to assets that a customer already controls, such as extended warranties for physical products or post-contract customer support (PCS) for licensed software, and cannot relate to
assets that the customer does not control or only may control in the future. While the Company may or may not conduct R&D activities on these programs, unless and until Celgene exercises one or more of its option, Celgene does not obtain control
of any aspect of that R&D effort. While the Company believes there is no implied promise here and certainly not one that is a performance obligation, the Company also considered that if there were an implied promise it would neither be capable
of being distinct nor distinct in the context of the contract. Because any R&D services performed by the Company would not convey control over the results of that R&D unless and until the related option is exercised because the R&D
relates only to the value of the underlying license which can only be captured by the customer in the event the option to such license is exercised. Therefore, the Company believes any such implied R&D promise would need to be combined with the
option to acquire a license. Because the R&D services do not convey control of a valuable asset by themselves and revenue attributable to the option to acquire a license to the underlying technology does not qualify for over time recognition,
the Company believes the combined unit of account would not be recognized as revenue until control of the underlying license was conveyed or the option to purchase the license expired.

The Company believes this also is consistent with the transaction economics. [***] Celgene does not obtain control over the underlying assets
unless and until it commits substantial additional funds by exercising the option. That is, the customer is willing to pay a relatively small fee now for potential access to a much more valuable program further into development. ASC 606 is clear
that payments associated with options cannot be recognized as revenue until the option is exercised (and the underlying goods or services delivered) or the right expires.

3.
 In your February 28, 2019 response, as part of your analysis of ASC 606 step 2, you identify a number
of “Prothena Obligation(s)” and conclude they are not distinct performance obligations. Because a performance obligation consists of a distinct good or service or a bundle of goods and services that are distinct, it is not clear whether
you are asserting that the items listed as “Prothena Obligation(s)” are not promised goods and services

 [***] Certain information in this
document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested by Prothena Corporation plc with respect to portions of this letter.

Confidential Treatment Requested by Prothena Corporation plc

PRTA-4

 Company Response:

The Company respectfully submits to the Staff the following analysis by the Company of the Agreement at contract inception in response to
Comment Number Three:

 Contractual Provision

 Promise

 Performance
Obligation

 Distinct

 Material

Participation on JSC

Yes1

Yes1

NA1

No1

US Right/IND Option to obtain underlying US License and ancillary services

Yes

Yes2

Yes

 Yes2 –

Material

 right

Global Right/Phase 1 Option to obtain underlying Global License and ancillary services

Yes

Yes2

Yes

 Yes2 –

Material

 right

Limited Licenses

Yes

No

No3

No

US and Global License

No4

No2

NA7

NA

Development services subsequent to US Right/IND Option Exercise

No4,8

No2,8

NA7

NA

 Development services subsequent to Global Right/

Phase 1 Option Exercise

No4,9

No2,9

NA7

NA

Delivery of manufactured compound

No4

No5

NA7

NA

Prosecution, maintenance and enforcement of patents

No6

No6

NA7

NA

Ancillary support including technology transfer

No4

No10

NA7

NA

1
 The Company determined that its participation on the joint steering committee and its subcommittees
(collectively, the “JSC”) represents a performance obligation; however, it is quantitatively and qualitatively immaterial in the context of the Agreement. Per ASC 606, an entity is not required to assess whether promised goods or services
are distinct if they are immaterial. The JSC has limited governance responsibilities and essentially serves as a mechanism for the Company to communicate and discuss with Celgene any research activities that the Company decides, at its sole
discretion, to undertake. Additionally, the Company’s responsibilities vis-à-vis the JSC operate only to ensure that Celgene remains informed and are substantively limited to making decisions regarding the research activities which the
Company chooses to undertake at its sole discretion.

2
 An entity only accounts for a customer option when it conveys a material right to the customer that it would
not receive without entering into the contract. Because Celgene has the option to acquire additional goods and services at a discount to the standalone selling price for those goods and services and Celgene would not be able to obtain these services
without entering into the contract, the options are deemed material rights. The material right is the performance obligation (US Right and Global Right), not the goods or services (US License and Global License and development services post-option
exercise) that the customer can purchase by exercising the option.

 [***] Certain information in this
document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested by Prothena Corporation plc with respect to portions of this letter.

Confidential Treatment Requested by Prothena Corporation plc

PRTA-5

3
 The limited licenses under Sections 7.1.1 and 7.1.2 of the Agreement (the “Limited Licenses”) are not
distinct because Celgene cannot benefit from the licenses on its own in a way that generates economic benefits.

4
 Promise is contingent upon option exercise.

5
 Inventory supply to the extent requested by Celgene to be paid to Prothena by Celgene at a reasonable
stand-alone selling price for such supply. Given that (i) there is substantial uncertainty about the development of the programs, (ii) the pricing for the inventory is at its standalone selling price, and (iii) the manufacturing
services require the entity to transfer additional goods or services that are incremental to the goods and services provided prior to the resolution of the contingency, there is no material right. Therefore, the Company’s supply of product is
not considered a performance obligation unless and until, requested by Celgene.

6